Senior Manager, Quality

Integer

Base: not specified; bonus/equity: cash-based ince...
Not specified (could imply flexible options based on company norms).
8+ years manufacturing experience
Iso 13485 and iso 9001 knowledge
Fda 21cfr820 regulatory compliance
Integer is seeking a Senior Manager of Quality to lead and enhance quality management systems in a manufacturing environment for medical device OEMs. The ideal candidate will possess strong leadership skills, regulatory knowledge, and a commitment to quality excellence, while benefiting from a comprehensive compensation and benefits package

Job Summary

  • The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they meet customer requirements while remaining in compliance with associated quality management system policies.
  • You will provide leadership for a team of Quality function professionals, including supervisors, engineers, and individual performers, fostering a culture where everyone owns quality.
  • Our total rewards program includes base salary, cash-based incentives, comprehensive medical/dental/vision benefits, and immediate eligibility for a 401(k) plan with company matching.

Matching Summary

Match Score: 85

Integer is seeking a Senior Manager of Quality to lead and enhance quality management systems in a manufacturing environment for medical device OEMs. The ideal candidate will possess strong leadership skills, regulatory knowledge, and a commitment to quality excellence, while benefiting from a comprehensive compensation and benefits package.

Salary

Base: Not specified; Bonus/Equity: Cash-based incentive program supporting pay-for-performance; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with match

Skills & Requirements

Must-have

  • 8+ years manufacturing experience
  • ISO 13485 and ISO 9001 knowledge
  • FDA 21CFR820 regulatory compliance
  • Root cause analysis expertise
  • CAPA and complaint handling leadership
  • Team supervision and development

Nice-to-have

  • Six Sigma Green Belt certification
  • ASQ Certified Manager of Quality
  • EU MDR familiarity
  • Hoshin planning experience
  • Diverse and inclusive culture champion
  • Strategic vision alignment skills

Key Requirements

  • Bachelor's degree in engineering or related technical field
  • Master's degree preferred
  • Minimum 8 years in manufacturing with ISO/regulatory focus
  • Prior supervisory or leadership experience required
  • Auditing experience with EU MDR and FDA regulations

Work Rights

Not specified

Tailored Resume

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