Imagine working for one of the leading contract manufacturers in the world. Trelleborg Medical Solutions is located 30 miles from California’s pristine Central Coast. As a premier manufacturer for life-saving medical components, Trelleborg Medical Solutions is a forward thinking company. We have been active in our lean manufacturing journey for many years and are advancing towards making our business a showcase of excellence in the medical industry.

Seize this rare opportunity to be part of a healthcare and medical business unit that has been in business for over 100 years, all while enjoying the benefits of living in one of California’s most desired locations!

Trelleborg is an Equal Opportunity Employer and offers an excellent benefits package that includes:

• Life Insurance
• Medical Insurance
• Vision Insurance
• Dental Insurance
• 401(k) plan
• Generous PTO plan
• 12 paid holidays

Currently, we have an opening for a Quality Engineering Supervisor. In this role, you will be responsible for leading a team of Quality Engineers, as well as providing leadership, functional management and oversight of other designated areas.

Some of the essential functions include:

• 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.
• Assigns projects and responsibilities to the direct reports. Ensures skill-sets of staff are in alignment with expected duties.
• Consults customers 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
• Works closely with internal resources to establish processes and resolve issues
• Drives best practices through the application of effective quality engineering principals and procedures across functions
• Ensures proper controls are being systematically applied to both new and legacy products
• Supports internal and external audits

Required:

• 4 year degree in Engineering or Science-related field
• 4 years of increasing experience providing technical support and leadership in regulated environment
• 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)

Desired:

• Quality certifications (ASQ CQE, CQA, CQM, etc.)
• Class I, II, III Medical Device Manufacturing experience
• Experience in coaching and utilizing performance management tools and disciplines
• 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
• Extensive experience with statistical analysis, Minitab software (or equivalent), GD&T and CAPA investigation and resolution

Estimated salary range $100,000-$120,000