Quality Engineer
Trelleborg leverages in-depth materials and applications expertise with early market insights, making the Group a world leader in engineered polymer solutions. We offer a unique portfolio covering a broad range of applications – even the most complex ones. In 2025, Trelleborg Group reported annual sales of approximately SEK 34 billion, with operations in around 40 countries. The Group comprises three business areas: Trelleborg Industrial Solutions, Trelleborg Medical Solutions, and Trelleborg Sealing Solutions. The Trelleborg share has been listed on the Stock Exchange since 1964 and is traded on Nasdaq Stockholm, Large Cap. www.trelleborg.com
Summary of the role
Responsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control operations. Working with internal and external customers supports, quality and continuous improvement using appropriate tools, project leadership.
Tasks and Responsibilities
- Knowledgeable and adheres to TMS Quality Management System and its requirements.
- Supports internal and external audit program as necessary.
- Supports customer complaint (CC), Non-Conforming (NC) events and materials, and CAPAs per procedures.
- Performs investigations, supports determination of the disposition of returned goods, determines re-inspection requirements, determines corrective and preventive actions (CAPA), issues complaint reports, supports completion of customer CAPAs, and approves to close. Looks for trends to determine actions to decrease number of NCs
- Initiates and performs root cause analysis. Uses statistical and capability analysis to solve problems. Implements and verifies CAPAs
- Performs trend analysis of CAPA, NCM, Complaint/Customer Feedback, Risk Management activities, Audits, etc. and presents periodic reports for management review.
- Authors and executes Quality Plans for Quality Management Systems and Organizational Objectives projects.
- Support TMS projects across sites from Quality perspective, as needed.
- Support Engineering, Manufacturing, NPD, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product quality.
- Communicates with customers on complaints, process changes, clarification of specifications, completing customer documents, and other projects as needed
- Conducts studies including Gauge R&R’s to develop inspection methods and test equipment. Creates measurement system programs, when necessary.
- Establishes inspections and sampling procedures to ensure the control of quality at the most economical costs
- Creates, reviews and approves Equipment Qualifications, Process, Cleaning, and Software Validation, pFMEA and other documentation as necessary.
- Works closely with internal resources to establish processes and resolve issues
- Supports implementation of best practices through the application of effective quality engineering principals and procedures across functions.
- Drives best practices through the application of effective quality engineering principals and procedures across functions.
Education and Experience
Required:
- 4 year degree in quality, engineering or any related field
- 5+ years in a regulated manufacturing environment
- Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable), EU/MDR.
Desired:
- Certified Six Sigma Yellow/Green
- ASQ Certified Quality Engineer and/or Auditor and/or equivalent
- Class I, II, and/or III Medical device manufacturing experience
Ansökan
Välj dina intresseområden
Jobbar du redan på Trelleborg?
Hjälp till i rekryteringen och hitta din framtida kollega. Ange din epost nedan för att få instruktioner om hur du blir en influencer.