Within Quality you define and specify activities, processes, or standards to fulfill the quality requirements for services, materials, components, or products.
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Quality is in the middle of it all. Employees work with production, finishing and determine when a product meets all customer requirements. If you like being a hands on, accurate, busy person, this job is for you.
The Quality Engineer is responsible for managing customer and supplier part approval documentation required for approval of new part submissions (NPI / APQP), part design and specification changes, and annual part revalidation when required by the customer.
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.
Location: Plymouth, MN
Trelleborg Medical Solutions is seeking a Metrology Technician to join the Plymouth, MN team. The Metrology Technician will partner with Quality Engineers and Metrology Engineers in developing, troubleshooting, standardizing, and improving new and existing measurement methods, systems, and procedures for new product release and legacy products. Follow good manufacturing practices (GMP) and principles to help develop and maintain the quality system.
As a valued team member with Trelleborg, you will enjoy:
Education and Experience
Required:
• 2 year degree in quality, manufacturing, engineering, or related equivalent experience
• Regulated manufacturing industry experience
Desired:
• 2+ years of regulated manufacturing experience.
• Quality certification(s) (e.g. ASQ CQE, CQT, CQA, etc.).
• Class I, II and/or III Medical Device manufacturing experience.
• Knowledge and experience with GMP/ISO Standards.
Job Responsibilities:
Metrology Technician:
• Assist Engineers with tasks related to measurement method development and support in compliance with quality regulations for medical device manufacturing
• Setup and conduct test method validation for variable and attribute test method validation activities, including sample creation, developing test method work instructions
• In coordination with site the quality team, calibrate measurement instruments and equipment at regular intervals, and perform preventative maintenance when applicable
• Develop robust measurement systems per medical device requirements, program CMM and automated vision systems, develop test methods for hand tools and gages
• Review, interpret, and analyze Geometric Dimensional and Tolerance (GD&T) requirements per specifications to perform test method development and validation
• Interpret specifications, drawings, customer documentation and other documents as necessary to support metrology projects
• Plan, coordinate, conduct 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• Support Engineering and Supplier Quality group in identification of equipment and/or calibration providers.
• Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product
• 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
• 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, Project, Access and JMP
• Comprehensive understanding of applicable Work Instructions, SOP’S, and ISO standards
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:
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:
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
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 November 29th 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.
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.
The application deadline for this role is 31/12/2024. 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 05/01/2025. 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.
“Don’t delay! We’re hiring as quickly as possible”
At Trelleborg our people are #shapingindustryfromtheinside
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.
The application deadline for this role is 31/12/2024. 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 05/01/2025. 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.
“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
Qualifications
Desired:
Competencies
Application
Last Application Date: November 30th 2024
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