Quality Engineering Supervisor
Trelleborg is a world leader in engineered polymer solutions that protect critical applications in demanding environments. Its innovative solutions accelerate performance for customers in a sustainable way. And we are where we are because our talents brought us here. In 2023, the Trelleborg Group had annual sales of approximately SEK 34 billion 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 listed on Nasdaq Stockholm, Large Cap. www.trelleborg.com
Why Join Us?
As a valued Trelleborg team member, you will enjoy:
- Greater opportunity for impact
- Competitive compensation
- Outstanding benefits package: Health, Dental, Vision, STD, LTD, Life, 401k
- Generous paid time off
- Bonus potential
Tasks & Responsibilities:
- Must be knowledgeable and adhere to TMS Quality Management System and its requirements.
- Drives and supports QMS initiatives and continuous improvement activities.
- Ensures direct reports are successfully performing their duties as assigned. Provides coaching on an ongoing basis.
- Ensure necessary training is defined, assigned, and executed for the direct reports.
- Assigns projects and responsibilities to the direct reports. Ensures skill sets of staff are in alignment with expected duties.
- Consults Quality Manager/Director on quality-related topics
- Establishes and develops site-specific processes as required/requested
- Reviews and approves processes, Quality Plans, protocols/reports, as necessary.
- Ensures proper resource allocation to support needs to ensure delivery expectations of customers.
- Provides recommendations for goals and objectives for the Quality Department
- Supports and coordinates management of nonconforming issues such as complaints, nonconforming materials and events, audit findings, and CAPAs.
- Drives best practices through the application of effective quality engineering principals and procedures across functions
- Ensures proper controls are being systematically applied to products
- Supports internal and external audits
- Provides recommendations based on data for improvements that are measurable.
- Other duties as assigned
Required:
- 4-year degree in Engineering or Science-related field
- 4+ years of increasing experience providing technical support and leadership in regulated environment
- Class I, II, III Medical Device and component manufacturing experience
- Experience in coaching and utilizing performance management tools and disciplines
- Extensive experience with statistical analysis, Minitab software (or equivalent), GD&T and CAPA investigation and resolution
Desired:
- Knowledge and experience with one or more: ISO/FDA: ISO 9000/9001; ISO 13485, and 21CFR Part 11/820 (and 4/210/211 as applicable)
- Quality certifications (ASQ CQE, CQA, CQM, etc.)
- Experience auditing (internal and external) for all elements of ISO 9001 and/or ISO 13485
- Experience with the successful completion of multiple projects for new product development or improvement initiatives
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