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
Responsibilities:

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