What are the responsibilities and job description for the Quality Engineering Supervisor position at Trelleborg Medical Solutions?

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] (https : / / eur02.safelinks.protection.outlook.com / ?url=http : / / www.trelleborg.com / &data=05|01|maria.rifaut@trelleborg.com|3b757bb991bb411d827708dba3044535|0f86117777224f068db93384e5321a9f|0|0|638283010950261273|Unknown|TWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0=|3000|||&sdata=8TeIdPxJaN2pjtmrQi19WoTwOZDKNZxQKFP0DilDVgc=&reserved=0)

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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