Quality

Imagine working for one of the leading contract manufacturers in the world. Seize this opportunity to be part of a healthcare and medical business unit with the support and stability of an organization that has been in business for over 100 years.

Apply here!

Trelleborg Medical Solutions  is seeking a Metrology Engineer to join their team.

Responsible to plan and coordinate Metrology activities to support tooling, automation, fixture, and medical device manufacturing.  Provide direction to advance the organization's metrology capabilities, identifying training, equipment, and resource needs.  Collaborate with New Product Development (NPD) teams to support metrology equipment qualification, software validation, test method development and validation, other quality processes to ensure compliance with the company's Quality System and applicable external requirements and standards, including FDA, ISO 13485, and/or other regulatory agencies as applicable to medical device manufacturing.  Working with internal and external customers to support creative approaches and solutions to problems.  This position is located in our Plymouth, MN site. 

As a valued Trelleborg team member, you will enjoy:

• A fulfilling career with greater opportunity for impact
• A fun and rewarding company culture
• Competitive salary
• Generous benefits package: Health, Dental, Vision, STD, LTD, Life, 401k
• Paid time off
• Paid holidays

Qualifications:

• Required:
  • 4 year degree in mechanical engineering or any related field
  • 2+ years in a manufacturing environment in a technical support role
  • Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)

  Desired:
  • ASQ Certified Quality Engineer
  • Formal Six Sigma Yellow/ Green belt training

Responsibilities:

Metrology Engineer:

• Lead, develop, and support measurement methods in compliance with quality regulations for medical device manufacturing
• Program CMM and automated vision systems, develop test methods for other tools and gages
• Review, interpret, analyze Geometric Dimensional and Tolerance (GD&T) requirements per specifications to perform test method development and validation
• Provide direction to internal teams to apply GD&T principles to internal designs
• Perform or provide guidance to Metrology Technician or Inspectors on complex First Article Inspection (FAI), prototyping, tool/fixture verification measurements
• Mentor Engineers and Technicians in troubleshooting of metrology equipment and gages, including repair and maintenance of advanced metrology equipment.
• Recommend equipment, sampling plans, and measurement techniques for inspection
• Work with the Supplier Quality group to ensure equipment and calibration provider is acceptable and qualified before use
• Provide recommendations on advancing metrology capabilities, identifying equipment and skills needed to support the organization’s growth strategy
• In conjunction with the NPD team, plan, develop and conduct equipment, software, test method, and/or process validation within the metrology scope
• Draft protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (IQ/OQ/PQ) for metrology
• Review specifications, drawings, quality agreements, customer documentation and other documents as necessary to support NPD projects
• Plan, coordinate, oversee Test Method Development and Validation activities, Initiate inspection plans for new/revised product
• Perform measurement system analysis (MSA) for Gage 1, Gage Repeatability and Reproducibility (GRR), Bias and Linearity, Resolution studies
• Perform statistical analysis of inspection data, process characterization, DOE results, ANOVA, Capability Analysis
• Support the risk management process identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA), CAPA etc.
• Author and executes Quality Plans for Quality Management Systems and Organizational Objectives projects
• Initiate and perform root cause analysis, uses statistical and capability analysis to solve problems
• Adhere to the company’s Quality System (QS), writes, and approves QS documents
• Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product
• Communicate with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects as needed
• Understand regulatory requirements (e.g. ISO13485, 9001, 14971, FDA 21 CFR 820, ITAR)
• Provide periodic work direction and assistance to QA inspectors, QA technicians and Quality Engineering Technicians
• Support internal audit program as necessary
• Support other quality activities as necessary such as customer complaint (CC) and RMA system per procedures, corrective and preventive actions (CAPA),
• Support internal and external audits

Competencies: 

• Ability to read, write, speak and understand the English language (with a help of a translator, if needed)
• Ability to communicate clearly by conveying and receiving ideas, information and direction effectively

Travel: 

• This position may provide support across H&M sites
• Estimated up to 25% travel

Apply here!

The quality inspector will be responsible for verifying both inbound and outbound inventory. They will ensure that our products meet Trelleborg standards as well as our customer requirements.

Tasks and Responsibilities:

• Inspect products using gauges, coordinate measuring machine, scales and vision data prior to shipment
• Test materials
• Abide by customer’s incoming inspection requirements
• Respond when supplier quality levels are suspect and inspect incoming product to assure the quality level
• Receipts must be inspected when defects are found until corrections can be verified
• Some materials may be inspected as marketing tool to demonstrate to our customers our high focus on quality
• Maintain proper documentation where necessary

Education and Experience:

• HS diploma
• 1 year experience in warehousing environment required
• Actively pursuing or if already hold a bachelors degree or associates degree preferred
• Minimum 1 year experience in quality inspection or similar function preferred
• Proficient in Microsoft office products including Microsoft Excel preferred

Competencies:

• Clear oral and written communication skills
• Ability to follow documented procedures and standards
• Basic computer skills
• Basic reading skills
• Basic arithmetic skills
• Time management skills including meeting deadlines for OTD
• Ability to successfully work independently

Benefits include:

• 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement

Application:

Apply here!

As an EEO/Affirmative Action Employer all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status.

​This position requires the use of information which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR.  ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. Green Card Holder), Political Asylee or Refugee. 

Summary

The primary role is the inspection of components to ensure compliance with specifications.

Tasks and Responsibilities

• Conducts inspections to ensure compliance with product specifications. Inspections include visual, dimensional, functional, and physical testing on product from all departments.
• Performs all duties per appropriate work instructions.
• Completes required documentation.
• Verifies packaging and documents for shipping parts.
• Performs accurate data entry.
• Collaborates and gathers documentation or data, tests product or materials for root cause analysis, investigations, and drives continuous improvement activities.
• Communicates orally in a professional, courteous manner. Written communications should be clear and concise.
• Serves as a good team player.
• Uses Lean Enterprise methods to reduce waste and complexity in all processes and organizes work area.
• Ensures the work area is clean and safe.
• Assists with filing or scanning for QA Dept.
• Able to accurately scan processing records to computer files for archiving.

Education and Experience

Required

• High School Diploma, or equivalent
• 0-3 Years experience in a manufacturing environment. 

Desired

• Experience with clean room manufacturing
• Experience with good manufacturing practices in a regulated industry

Competencies

• Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
• Ability to demonstrate adequate job knowledge to deliver a world class performance
• Ability to challenge oneself to consistently meet all goals and deadlines
• Willingness to strive for excellence by producing work that is free of errors and mistakes
• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
• Commitment to making improvements company wide
• Demonstrated Intermediate skills using Microsoft Office and set up meeting in Outlook
• Comprehensive understanding of applicable Work Instructions and Standard Operating Procedures
• Comprehensive understanding of quality control and production documentation
• Proven competency with applicable inspection equipment including, but not limited to, comparators, microscopes, calipers, tensile tester, scales and gauges
• Working knowledge of prints and customer supplied drawings and documentation
• Good manual dexterity
• Correctable normal reading distance vision
• Good organizational skills with the ability to pay strict attention to details
• Ability to work with minimal supervision, follow directions and make sound decisions
• Strong team skills
• Understanding of acceptance sampling
• Ability to maintain a professional and respectful relationship with coworkers and company
• ability to read, write, speak and understand the English Language 

Application

Last Application Date: 11/30/2024

Apply Here

Please right-click the link to open in a new tab. 

At Trelleborg Sealing Solutions, we enhance automotive performance, ensure stable aircraft landings, and enable excavators to break through the impossible. Our customers commend us for our high-quality standards - standards we set for each other, our suppliers, and especially our products.

At Trelleborg Sealing Solutions in Helsingør, we are a team of 320 dedicated colleagues specializing in the development and production of sealing systems for high-tech companies in the hydraulic, automotive, aviation, shipbuilding, offshore, and machinery industries.

The Team, Your Role, and Your Responsibilities
As a Quality Inspector & Measuring Specialist, you will join our Quality Control department, which consists of 15 employees. Your future colleagues are all highly competent and driven by a fundamental desire to make things happen. Together, we strive to improve each other’s skills, use our differences constructively, and develop. However, we need your expertise to reach our goals and become even better.

Your primary responsibility will be as the QC lead in measurement related tasks across the site. You will act as QC responsible in our APQP team (Advanced Product Quality Planning), be responsible for the FMEA establishment and maintenance, for CPK evaluation and reporting and further provide and support PPAP (Production Part Approval Process) documentation. You will act as decision maker during evaluation of geometric measuring equipment´s capability to meet customer-specific requirements.

You will be responsible for development and maintenance of SPC SW, measuring programming for e.g., optical measuring equipment and subsequent training of operators. Further, development, implementation and maintenance of quality tools and procedures, and assist QC in cases of dispensations and non-conformities.

Who We Are Looking For
We are seeking a Quality Inspector & Measuring Specialist with a strong background in measuring techniques, measuring programming (2D/3D machines) and statistics (e.g., SPC, CPK), preferably from a production company. You have experience with risk management tools, such as FMEA and preferable with GPS (Geometric Production Specifications). You are familiar with LEAN principles and preferable also APQP and PPAP. Knowledge of MSA Type 1, 2 and 3 is an advantage. Your educational background is on a B.Sc. or M.Sc. level. Fluent Danish and English required.

You’re a team player with a positive, proactive, and open attitude. You’re structured, analytical, and comfortable communicating at all levels of the organization. You’re actionable and capable of making decisions. Your humor and joy in life build bridges. You thrive in a hectic everyday life, and you take pride in seeing your tasks through to completion. You meet people and your work with openness, firmness, and curiosity.

We Offer More Than Just a Job
This position will give you the opportunity to develop your career together with some of the best and most dedicated technology experts from around the world in a leading company in the industry. You will be able to influence the development of your team, our quality control framework and development and can expect collaboration with colleagues from all departments.

Freedom under responsibility is the framework under which Trelleborg’s employees work. This ensures a good balance between work and family life, as well as constant development of both professional and personal skills in an international and positive environment.

Lastly, we provide an employee association that hosts a variety of social, cultural, and active events. We also have an art association, and not to forget, our fantastic canteen that daily serves incredible breakfast and lunch.

Want to become a part of Trelleborg Sealing Solutions?
If you’re passionate about driving changes in the field of Quality Control Measuring and want to be part of a company that prioritizes job satisfaction, quality, responsibility, and commitment, we encourage you to apply by October 31st by sending us your application and CV via the form below.

If you have relevant questions about the position, you are welcome to contact Sandra Eriksen, Head of Quality at: [email protected] or +45 3146 8639.

Trelleborg Sealing Solutions is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We encourage applications from individuals of all genders, nationalities, ages, religions, identities, and experiences.

1. Summary of the role:

This job description details the responsibilities of the TSS Long Thanh Quality Manager, reporting directly to the General Manager. The main responsibilities of the role include:

• Ensure all Quality Control and Quality Assurance activities are supported and continually reviewed in relation to improvements in Quality, cost and delivery goals.
• Manage the Product Verification team to ensure the manufactured product meets visual and dimensional specifications.
  • Assist in supporting the business development teams to ensure new product introductions are successful.

2. Tasks and Responsibilities:

• Ensure adherence and compliance in order to maintain accredited systems required by the business and its customers i.e. ISO 9001:2015, ISO 16949:2009, ISO 14001:2015.
• To manage the delivery of FAIRs, 3.1s, Inspections Plans or any other certification requirements specified by customers.
• Participate as a key stakeholder in the reviewing of engineering designs to contribute quality requirements and considerations (e.g. quality lead in APQP, FMEA processes). Assists product support areas in gathering and analysing data.
• To co-ordinate the response to internal escapes and customer complaints, driving improvements and preventative actions through 5Y and 8D processes.
• To work with the purchasing department to ensure suppliers meet quality expectations and to address supplier quality issues.
• Manage the Product Verification activities to ensure that product is inspected in accordance with the correct prioritisation and within the timescales required to support On Time Delivery (OTD).
• Appraisal performance of team members to develop and improve individuals.
• Liaising with other TSS Quality teams to support industry specific requirements and expectations.
• Develop and lead the schedule for internal and external audits.

3. Education and Experience:

• A technical degree or equivalent is desirable.
• Minimum of 5-7 years related experience, including experience of working closely with design engineering functions and production functions.
• Demonstrated increased responsibility level throughout career, including management of multidisciplinary teams.

4. Competences:

• Ability to build and sustain good relationships with a range of internal and external stakeholders
• Excellent communicator – both verbally and in writing – of technical and business subject matters
• Openness to work with international individuals and be involved in interdisciplinary collaborations
• Be self-motivating and able to work with minimum supervision when required
• Well organized, good time management. Able to meet deadlines
• Good leadership and stakeholder influencing skills
• Knowledge of manufacturing processes
• Strong analytical and problem-solving skills
• Strong IT skills (good familiarity with MS packages, able to use ERP systems)
• Appropriate knowledge of relevant Safety and Environmental regulations and procedures.

5. Key Interfaces and Stakeholders:

• Customers (TSS, External Customers)
• Suppliers (e.g. Raw Materials, Compounders, Test Houses)
• TSS Long Thanh. All Departments
• TSS Group colleagues

6. Geography to cover and travel requirements:

• This position is largely based at TSS Long Thanh however, the role will include the need to travel overseas occasionally.
• There will also be some, occasional, travel within the UK.

7. Behavioral Characteristics:

• Set an example by actively contributing to departmental and company goals
• Take initiative with respect to personal development, seeking additional training or direction, as needed
• Build quality into work. Ensure processes are consistent with the company quality objectives
• Make suggestions for improvements in areas of cost management, processes and quality
• Able to work well as part of a team
• Must be able to work independently, accurately and efficiently

Do you want to experience new challenges and innovate the future of engineered polymer solutions? Accelerate your career with Trelleborg and start shaping industry from the inside.

Who Are We?

Trelleborg Industrial Solutions (TIS) is a global leader in innovative polymer-based solutions for key industries and critical infrastructure. We are one of two Business Areas within the Trelleborg Group, with a total of about 6 200 employees around the world. 

About Trelleborg Marine & Infrastructure business unit - with our comprehensive portfolio of smart engineered solutions designed for berthing, docking, and mooring, navigation and piloting, built and offshore infrastructure, we work to meet some of the core challenges centered around safety, efficiency, and sustainability. Join us and be part of a world-class team that is dedicated to excellence and innovation.

About the Job

I. General information:

1. Job Title: Quality Engineer (Rubber focused)
2. Report to: Quality Manager
3. Working Location: Phu My 3 Specialized Industrial Park, Ba Ria & Vung Tau Province, Vietnam (Shuttle bus will be provided from 3 locations: Ho Chi Minh City, Bien Hoa City, and Vung Tau City)

II. Summary of the role:

• Develop and implement quality control including material, process and products.
• Analyze quality problem and take the countermeasure.
• Summarize and analyze quality data , find quality problem and solve it.
• Quality improvement including incoming, process, finished product.
• Handle customer complaint and make the NCR report.
• Supplier quality management.

III. Tasks & Responsibilities:

• Compile inspection standard of material,process and products,then conduct inspector operation
• Analyze quality problem with relative members in time and take the countermeasure
• Summarize and analyze quality data, find root cause and solve it.
• Analyze customer complaint with relevant stakeholders. Take the countermeasure and make 8D report.
• Product testing and reporting.
• Products witness including 3rd party and client.
• Compile and keep ISO procedure.
• Quality improvement including incoming, process, finished product.
• Supplier quality management.
• Others assigned by Manager.

About the Ideal Candidate

• Bachelor's degree in electrical engineering, mechanical engineering, or a related field.
• Minimum 3 years' experience as quality engineer in Rubber manufacturing field.
• Lean six sigma qualification is preferred.
• Familiar with quality tools, such as SPC, MSA and so on.
• Familiar with ISO management system. Internal auditor is preferable.
• Strong quality mindset and process improvement.
• High communication and executie skill.
• Good computer skill, especially in Microsoft office.
• Good working attitude and teamwork spirit.

Why You'll Love Working with Us?

• Generous Paid Time Off: Enjoy 16 days of annual leave to relax, recharge, and pursue your passions outside of work.
• Comprehensive Health Coverage: Stay healthy and worry-free with Private Health Insurance from PTI, covering not only you but also all of your loved ones! (Husband/Wife/Childrens)
• Security from Day One: We fully cover your Social Insurance contributions, even during your probation period, ensuring peace of mind right from the start.
• Competitive Rewards: Benefit from a 13th-month salary and a performance-based KPI bonus of up to 2 months.
• Convenient Commute Options: Forget the hassle of commuting! We provide a comfortable Shuttle Bus service from Ho Chi Minh, Bien Hoa, and Vung Tau straight to our factory.
• Additional Perks & Allowances: Enjoy added support with allowances for lunch, phone, and petrol, making your work-life smoother and more comfortable.
• Accelerated Learning and Growth: As a newly established company, we have a lot of exciting projects ahead! This means you'll have numerous opportunities to learn, grow, and make a real impact right from the start.
•  

Application Process

The application deadline for this role is 15/09/2024. After this date, our team will review all applications, and shortlisted candidates will be contacted within 3 working days. If selected, you can expect to hear from us by 18/09/2024. We appreciate your patience and interest!

Trelleborg is an equal opportunity employer! We celebrate diversity and are committed to creating an inclusive environment for all employees. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Call to Action

“Don’t delay! We’re hiring as quickly as possible”

At Trelleborg our people are #shapingindustryfromtheinside 

Imagine leveraging your strong Quality experience for one of the leading contract manufacturers in the world. Seize this rare opportunity to be part of an exciting Healthcare and Medical Business Unit with the support and stability of an organization that has been in business for over 100 years.

Trelleborg Medical Solutions is seeking a Quality Director to join their team. The position is responsible for the Leadership and management of personnel and resources to ensure adherence and compliance to Trelleborg Medical Solutions Quality Management System (QMS) processes and policies.

Qualifications:

Required:

• 4-year degree in manufacturing or industrial engineering, quality assurance, regulatory affairs, science, or related field
• 10 years’ experience in quality assurance and/or regulatory affairs
• 5+ years Leadership/Supervisory-level experience, with decision-making authority/responsibility
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, FDA 21CFR 820/11 (4/210/211) and other Regulatory as applicable
• Class I, II, and/or III (or equivalent) medical device manufacturing experience
• Auditor certificate or equivalent experience with both internal and external regulatory agencies

Desired:

• Master’s degree in science, engineering, or equivalent
• ASQ Certification for CQA, CQM, Lean Six Sigma Black Belt Certification
• 5 years in Medical Device or Medical Device Supplier environment

Responsibilities:

• Drive, conduct periodic reviews, and support QMS initiatives as well as implement and report on continuous improvement activities.
• Ensure the promotion and awareness of regulatory and customer requirements throughout the organization.
• Establish and monitor Quality Department goals and objectives.
• Ensure and manage the processes and functions needed for employees to execute, implement, and maintain Quality Systems and its standards, specific to:
• Corrective Action/Preventative Action System
• Quality Manual
• ISO Certifications
• Equipment/Software/Environmental Control System
• Non-conformance System
• Document and Record Control System
• Supplier Quality and Materials Control System
• Management Control System

Customer Feedback/Control System

ITAR (Empowered Official Responsibility)

• Quality Systems supporting Production and Process Controls
• Provide resources for new product reviews and customer correspondence pertaining to projects or complaints.
• Provide resources for review, control and maintenance for all Quality System required documentation.
• Manage, develop, mentor, coach, and review Quality department employees.
• Manage annual internal audits on all relevant Quality Systems and serve as Quality representative for Customer and Regulatory audits.
• Serve as the Quality Management representative for the organization.
• Ensure establishment and maintenance of site regulatory registrations.
• Lead and/or support QS integrations for existing and future organizational acquisitions.
• Support for integration of new manufacturing capabilities, product transfers, development programs, and customers.
• Promote and support a Quality Culture throughout the organization.
• Other duties as assigned

Competencies:

• Ability to read, write, speak and understand the English language
• Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
• Ability to demonstrate adequate job knowledge to deliver a world class performance
• Ability to challenge oneself to consistently meet all goals and deadlines
• Willingness to strive for excellence by producing work that is free of errors and mistakes
• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
• Commitment to making improvements company wide
• Demonstrated competence using Microsoft Office
• Demonstrates senior leadership abilities with capability to accept responsibility and delegate authority
• Professional demeanor working with others
• Good math skills
• Good technical writing skills
• Working computer knowledge of Word, Excel
• Comprehensive working knowledge of applicable corporate policies, Work Instructions, and other procedures
• Ability to give directions, make decisions, give constructive criticism
• Competent knowledge of quality control evaluation devices including comparators, microscopes, pull tester, scales, and gauges
• Ability to interpret engineering drawings, specifications and other customer documents to support required inspections
• Ability to maintain a professional and respectful relationship with coworkers and company
  • Desire to delight both internal and external customers by offering encouragement, fostering teamwork and addressing conflict appropriately
• Statistical analysis, technical writing, non-contact measurement device

Geography to cover and travel requirements.

Up to 25% travel, as required

Do you want to experience new challenges and innovate the future of engineered polymer solutions? Accelerate your career with Trelleborg and start shaping industry from the inside.

Who are we?

Trelleborg Industrial Solutions (TIS) is a global leader in innovative polymer-based solutions for key industries and critical infrastructure. We are one of two Business Areas within the Trelleborg Group, with a total of about 6 200 employees around the world. 

About Trelleborg Marine & Infrastructure business unit - with our comprehensive portfolio of smart engineered solutions designed for berthing, docking, and mooring, navigation and piloting, built and offshore infrastructure, we work to meet some of the core challenges centered around safety, efficiency, and sustainability. Join us and be part of a world-class team that is dedicated to excellence and innovation.

About the Job

I. General information:

1. Job Title: Quality Manager
2. Report to: Vietnam General Manager
3. Subordinates: Quality Engineer
4. Working Location: Phu My 3 Specialized Industrial Park, Ba Ria & Vung Tau Province, Vietnam (Shuttle bus will be provided from 3 locations: Ho Chi Minh City, Bien Hoa City, and Vung Tau City)

II. Summary of the role:

• Establish, maintain, and improve company Quality management systems to ensure that all quality functions in the areas to meet internal and external quality expectations
• Develop and implement a systematic procedure to evaluate supplier quality management systems, identifying gaps and establishing corrective actions
• Responsible for plant quality assurance effort with emphasis on identification and solution of process, material or labor problems that could compromise plant commitments on quality.
• Responsible for testing & inspections, to ensure incoming, process, and finished products meet requirements of customers and company.
• Preparation of all external quality reports for customers to meet contract and project requirement.
• Responsible for internal quality report to identify problems, promote project management in areas involving quality, and resolve problems. Using QA/QC tools and methodologies for the analysis of quality issues and come up with improvement plan or proposal.

III. Tasks & Responsibilities:

• Formulated the company's quality objectives, monitored the completion of the objectives, reported to the general manager and management meeting in a timely manner, and took corresponding measures to ensure the realization of the objectives;
• Monitored the company's internal production performance and promoted quality improvement to reduce scrap rate and waste cost;
• Monitor customer feedback and complaints to ensure 100% customer response rate within a limited period. At the same time, conduct thorough analysis and countermeasures for each feedback, and standardize countermeasures to avoid recurrence;
• Monitor the material quality of suppliers and assist suppliers to improve the quality to meet the material quality requirements;
• Monitor the change point management of the company, including design change, process change, material change, supplier change, etc., to ensure the stability of product quality after the change;
• Responsible for customer factory audit, pass customer audit and show the highlights of the company;
• Responsible for the staff management, guidance and training of the quality members, so that they have the ability to work on the job, and gradually become capable and willing excellent staff;
• Working together with Sales, Production, and other team for new product / new application development
• Working together with Production, Technical, and Supply chain for project review and FAT protocol
• Deal with customers and related parties on quality requirements and complaints
• Contribute to the creation and implementation of strategy, policies, processes, and procedures & best practice Lean vision to aid and improve operational performance
• Making headcount plan according to business forecast, recruiting & training of operators to meet the need of production (combined effort with HR), measuring operators’ performance and maintaining an effective salary & compensation system; Confers with management and colleagues to solve workers problems, complains and grievance
• Close cooperation with other departments, particularly Production, Supply chain, Technical, Purchasing, and Sales departments

About the Ideal Candidate

• Engineering bachelor’s degree or above.
• Minimum 5 years experience as manager.
• Minimum 3 years MNC working experience.
• Familiar with ISO9001, ISO14001 and ISO45001 management systems.
• Lean six sigma qualification is preferred.
• High communication and executie skill.
• Good working attitude and teamwork spirit.
• Good computer skill, especially in Microsoft office.
• Fluent English in oral communication and writing. 

What we offer?

• Generous Paid Time Off: Enjoy 16 days of annual leave to relax, recharge, and pursue your passions outside of work.
• Comprehensive Health Coverage: Stay healthy and worry-free with Private Health Insurance from PTI, covering not only you but also all of your loved ones! (Husband/Wife/Childrens)
• Security from Day One: We fully cover your Social Insurance contributions, even during your probation period, ensuring peace of mind right from the start.
• Competitive Rewards: Benefit from a 13th-month salary and a performance-based KPI bonus of up to 2 months.
• Convenient Commute Options: Forget the hassle of commuting! We provide a comfortable Shuttle Bus service from Ho Chi Minh, Bien Hoa, and Vung Tau straight to our factory.
• Additional Perks & Allowances: Enjoy added support with allowances for lunch, phone, and petrol, making your work-life smoother and more comfortable.
• Accelerated Learning and Growth: As a newly established company, we have a lot of exciting projects ahead! This means you'll have numerous opportunities to learn, grow, and make a real impact right from the start.
•  

Application Process

The application deadline for this role is 30/09/2024. After this date, our team will review all applications, and shortlisted candidates will be contacted within 3 working days. If selected, you can expect to hear from us by 03/10/2024. We appreciate your patience and interest!

Trelleborg is an equal opportunity employer! We celebrate diversity and are committed to creating an inclusive environment for all employees. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Call to Action

“Don’t delay! We’re hiring as quickly as possible”

At Trelleborg our people are #shapingindustryfromtheinside 

Job Summary

Join our team as a Quality Systems Specialist at Trelleborg, where you will play a pivotal role in upholding quality assurance standards and ensuring compliance with regulations. The Quality Systems Specialist is focused on the maintenance of the Quality Management System (QMS) to ensure compliance with regulatory, quality, company policies and manufacturing requirements.

Tasks & Responsibilities

• Supports all aspects of the internal audit program, ISO notified body audits, customer audits and FDA inspections, including but not limited to:
• Serve as an auditor for internal audits
• Create and maintain internal audit schedule
• Audit controlled document files in preparation for regulatory inspections and provides support during regulatory inspections and client audits
• Initiate and execute audits, including developing and documenting the audit plan, leading the audit, generating the audit report, and tracking subsequent actions with the team
• Provide support during external audits including scheduling, hosting, preparing audit responses
• Work with subject matter experts to ensure audit record content is accurate, well documented, and meets the requirement of the process
• Develops metrics and performs trend analysis of key QS areas such internal and external audit findings, CAPAs, nonconforming material, training, deviations, etc. to identify areas for improvement. Escalates trends to an appropriate quality system such as CAPA or CI; presents analysis to management
• Supports maintenance of the CAPA program
• Serves as CAPA Owner as needed, driving necessary investigation, correction, and corrective/preventive actions
• Ensures all internal and external audit findings are entered into the CAPA system, assigned to the appropriate personnel, and are completed in accordance to the CAPA procedures, within specified time periods
• Approve corrective action plans and verify effective and timely implementation of corrective actions for audit nonconformities
• Oversees completion and control of customer questionnaires and other customer-required documents
• Initiates, facilitates and/or manages projects to expand, change, enhance and improve the quality system, as assigned
• Supports and coordinates activities related to nonconforming material, complaint/customer feedback, deviations, RMA, and CAPA processes
• Provides quality system training for the organization as needed
• Manages review of documents to ensure ISO/FDA compliance of controlled documents lifecycle including annual review management
• Ensures all work is performed and documented in accordance with GMP requirements and existing company policies and procedures

Qualifications

• Minimum of 2-year degree in Quality, Regulatory, Business or related field; OR certificate in Regulatory Science or Medical Product Development plus 1 year of regulated industry work experience required

Desired:

• 4 year degree in Quality, Regulatory, Business or related field
• ISO13485:2016 and/or ISO9001:2015 Auditor Certification
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)
• 3+ years of quality/regulatory experience in medical device or related industry
• 1 year experience conducting investigations and root cause analysis for complex/advanced issues

Competencies

• Ability to read, write, speak and understand the English language
• Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
• Ability to demonstrate adequate job knowledge to deliver a world class performance
• Ability to challenge oneself to consistently meet all goals and deadlines
• Willingness to strive for excellence by producing work that is free of errors and mistakes
• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
• Commitment to making improvements company wide
• Demonstrated competence using Microsoft Office
• Comprehensive understanding of applicable cGMP requirements, including ISO standards, and FDA and other QS regulations
• Comprehensive understanding of internal documentation (e.g., QS Manual, SOPs, etc.) and records and how they relate to cGMP requirements
• Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
• Experience with metrics development and data analysis
• Able to provide compliance guidance based on knowledge of regulations, available relevant information, alternatives, and risk
• Able to perform math functions
• Effective trainer and project leader
• Good manual dexterity
• Ability to maintain a professional and respectful relationship with coworkers and company representatives

Application

Last Application Date: October 31st 2024

Apply Here

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