Senior Manager, Quality Engineering

Responsibilities:

• Attract and retain talent for Quality Engineering, Supplier Quality, and Receiving Inspection; support development.
• Create a culture of quality ensuring compliance with QMS, FDA QSR, ISO, MDR, and international requirements.
• Support regulatory agency and notified body audits/inspections.
• Drive process validation, test method development, statistical analysis, and improvement projects.
• Collaborate with CAPAs, non-conformances, and risk management to focus on process improvement.
• Use judgment for prioritization and tradeoffs between schedule, scope, and cost.
• Partner with R&D, Maintenance, Operations, Quality Assurance, and others to resolve quality issues and drive high-quality outcomes.
• Lead oversight of the nonconformance system (product and non-product) and mentor problem-solving/root-cause activities.
• Mentor and drive continuous improvement to prevent issues and resolve them efficiently.

• Bachelor’s degree in a sciences/technical area relevant to medical devices.
• 7+ years medical device industry experience; 5+ years management experience.
• Extensive knowledge of government regulations for Quality Systems.
• Knowledge of international quality systems: ISO 9001/EN 46001, ISO 13485, MDR, vigilance systems, notified bodies, CE marking, IEC 60601.
• Strong collaboration, team building, negotiation/conflict resolution.
• Working knowledge of CAPA;
  Supplier Management;
  Risk Management (ISO 14971, FMEAs/FMECA, hazard analysis).
• Strong organizational/planning skills; ability to meet deadlines.

• Medical (includes prescription), Dental, Vision, Flexible Spending Accounts, 401(k) match, discretionary time off, paid sick time, stock purchase plan, tuition reimbursement, parental leave, short- & long-term disability, life and accidental death/dismemberment insurance, paid holidays, referral bonuses, employee discounts.