Quality Engineer IV - Medical Devices

About the role

This Quality Engineer IV leads the Workcell Quality Operations or NPI team, including Quality Engineers, technicians and inspectors. The role implements quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and data analysis, and ensures performance and product quality meet company, customer and regulatory requirements. It also involves leading investigations of quality discrepancies and acting as Validation Owner.

Key responsibilities

• Lead the development, modification and maintenance of quality evaluation and control plans and protocols for materials processed into partially finished or finished products.
• Own methods and procedures for inspecting, testing and evaluating product precision and accuracy, and approve batch record documentation and revisions to manufacturing processes.
• Support quoting activities by taking part in initial process design, development and implementation.
• Lead quality operations planning, ensure correct execution of quality tests for product release, and act as Validation Owner, including supporting plant Quality System software validation and ISO 13485, CFR 21 Part 820 and local requirements.
• Design and analyse inspection and testing processes and equipment, run quality assurance tests, and perform statistical analysis of non-conforming products or materials.
• Audit quality systems, help complete CAPAs in line with ISO 9001 and ISO 13485, and may own CAPAs.
• Manage the internal supplier third party, take part in FDA quality audits, and supervise, train or mentor QA Engineers, Inspectors and Technicians.
• Set measurable goals, evaluate team members, maintain the matrix for direct reports, and support EHS and safety programs.

Required profile

• Bachelor's degree and seven years of related experience, or an equivalent combination of education and experience.
• Experience in the medical device industry and a strong understanding of ISO 13485 requirements and compliance.
• Proficiency in English, written and spoken.
• Certified Quality Engineer (ASQ CQE) preferred.
• Knowledge of PCBA manufacturing processes and electronic components is preferred.

Required skills

• Expert-level use of Minitab and quality statistical tools.
• High-level competence in the ASQ Quality Engineering body of knowledge.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint) and email.