Quality Engineering Manager-Medical Device
Trelleborg is a world leader in engineered polymer solutions for almost every industry on the planet. And we are where we are because our talents brought us here. By specializing in the polymer engineering that makes innovation and application possible, Trelleborg works closely with leading industry brands to accelerate their performance, drive their business forward—and along the way, shape the industry and progress that will benefit humankind in the exciting years ahead.
Its innovative solutions accelerate performance for customers in a sustainable way. In 2022, the Trelleborg Group had annual sales of approximately SEK 30 billion in around 40 countries. The Group comprises two business areas: Trelleborg Industrial 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.
Imagine leveraging your quality & leadership skills while working for one of the leading contract manufacturers in the world. Seize this rare opportunity to be part of an exciting, Healthcare and Medical Business Unit with the support and stability of an organization that has been in business for over 100 years.
Trelleborg Healthcare and Medical is seeking a Quality Engineering Manager to join their team The Quality Engineering Manager is responsible for leading a team of Quality Engineers, as well as providing leadership, functional management and oversight of other designated areas.
As a valued Trelleborg team member, you will enjoy:
- A fulfilling career with greater opportunity for impact
- A fun and rewarding company culture
- Competitive salary
- Generous benefits package: Health, Dental, Vision, STD, LTD, Life, 401k
- Paid time off
- Paid holidays
- Quarterly bonus
Qualifications:
- 4-year degree in Engineering or Science-related field
- 6 years of increasing experience providing technical support and leadership in medical device manufacturing environment
- 2 years Leadership/Supervisory-level experience, with decision-making authority/responsibility
- Quality certifications (ASQ CQE, CQA, CQM, etc.)
- Class I, II, III Medical Device Manufacturing experience
- Knowledge and experience with ISO/FDA: ISO 9000/9001; ISO 13485, and 21CFR Part 11/820 (and 4/210/211 as applicable)
Desired
- Experience in coaching and utilizing performance management tools and disciplines
- Experience in a CMO producing Medical Devices
- Experience with ERP, Document Control, MES, and other types of software
- 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
- Must be knowledgeable and adhere to H&M Trelleborg 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.
- 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
Application
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