Quality

Er du passioneret omkring kvalitetssikring? Har du lyst til at arbejde med audits, afvigelses- og reklamationsbehandling? Og besidder du stærke engelskkundskaber, kommunikationsevner og et positivt mindset? Så kunne du være vores nye kollega i Trelleborg Sealing Solutions Helsingør.

Vi er 325 engagerede kolleger hos Trelleborg Sealing Solutions i Helsingør, og vi er specialiserede i udvikling og produktion af tætningssystemer til højteknologiske virksomheder. Selvom vi måske ikke er så kendte i den brede befolkning, er vi blandt verdens bedste inden for vores felt, og vi anerkendes af vores kunder for vores produkter og kvalitet. Vi er en del af den børsnoterede Trelleborg Group, som har knap 17.000 medarbejdere fordelt over hele verden.

I din rolle som Quality Assurance Specialist vil du sammen med resten af teamet være med til at sikre og videreudvikle kvaliteten i alt, hvad vi gør. Du får en bred berøringsflade med vores interne afdelinger og kunder, og du vil være med til at sikre, at vi lever op til vores certificeringer og KPI’er. Du kan se frem til en selvstændig rolle, hvor du har mulighed for at påvirke organisationen i en fortsat positiv retning, samtidig med at du udvikler dine faglige kompetencer.

Dine primære arbejdsopgaver vil bestå af:

• Gennemførelse af interne audits og leverandøraudits, samt facilitere vores eksterne audits
• Reklamationsbehandling – herunder oprettelse og opfølgning både internt i TSS Helsingør, men også med vores interne kunder i bl.a. Tyskland, Frankrig og England
• Afvigelseshåndtering og support til denne proces
• Videreudvikling af bl.a. vores QMS-system, træningssystem og vores SOP-beskrivelser
• Understøttelse af et kvalitetsbevidst-mindset på tværs af organisationen, så alle løbende tænker kvalitet ind i det arbejde der udføres

Hvad skal du kunne for at blive en succesfuld QA Specialist hos os?
For at få succes i rollen skal du have et stærkt kvalitets-mindset, være grundig, proaktiv og arbejde analytisk og systematisk. Du skal kunne kommunikere flydende på både dansk og engelsk i skrift og tale, og evnen til at bruge data og sætte dem ind i en meningsfuld kontekst er afgørende. Du er fuld af gå-på-mod, møder alle med en positiv og imødekommende tilgang, værdsætter samarbejde, og du sætter pris på den direkte kontakt med dine kollegaer i både produktion og administration.

Vi søger en dygtig kollega til at styrke vores interne auditprogram og til på sigt at varetage vores eksterne audits. Det vil derfor være en stor fordel, hvis du har erfaring fra en lignende stilling, gerne i en større produktionsvirksomhed. Du skal have kendskab til ISO 9001-standarden og har måske endda også udført interne audits i henhold til den. Det er desuden et plus, hvis du har kendskab til IATF 16949 og/eller AS9100.

Hvad kan vi tilbyde dig?

• En afvekslende arbejdsdag, fyldt med udfordringer i en stor international koncern
• Godt arbejdsklima med fleksibilitet, en uformel tone og højt humør
• Sparring og støtte fra motiverede og engagerede kolleger
• En karriere i en af branchens førende virksomheder med anerkendte produkter
• Mulighed for personlig og faglig udvikling; både i interne optimeringsopgaver på tværs af afdelinger, men også i vores globale samarbejde
• Sundhedsforsikring
• Personaleforening med mange forskellige tilbud, kunstforening og en helt fantastisk morgenmads- og frokostordning

Skal du være med til at sikre fortsat høj kvalitet hos Trelleborg Sealing Solutions?
Så vil vi glæde os til hurtigst muligt, og senest den 30. september, at modtage et fyldestgørende CV og en motiveret ansøgning via formularen nedenfor. 

Vi holder samtaler løbende og forbeholder os retten til at fjerne opslaget, når den rette person dukker op; så vent ikke for længe med at søge.

Har du spørgsmål til stillingen, er du velkommen til at kontakte Quality Manager, Sandra Eriksen, på telefon: +45 3146 8639.

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
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 (experienced in Mechanical & Electrical is required, possess experience in Rubber is an advantage)
• 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 2 of your loved ones!
• Security from Day One: We fully cover your Social Insurance contributions, even during your probation period, ensuring peace of mind right from the start.
• Additional Perks & Allowances: Enjoy added support with allowances for lunch, phone, and petrol, making your work-life smoother and more comfortable.
• 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.

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 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!

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

Trelleborg Healthcare and Medical 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!

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 2 of your loved ones!
• Security from Day One: We fully cover your Social Insurance contributions, even during your probation period, ensuring peace of mind right from the start.
• Additional Perks & Allowances: Enjoy added support with allowances for lunch, phone, and petrol, making your work-life smoother and more comfortable.
• 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.

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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