Senior Manager, Quality

Integer

Base: $150,000 - $220,220; bonus/equity: cash-base...
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8+ years manufacturing experience
Iso 13485 and fda 21cfr820 knowledge
Root cause analysis and capa leadership
** Integer is seeking a Senior Manager of Quality with extensive experience in manufacturing and quality management systems to lead teams and ensure compliance with regulatory requirements. The ideal candidate will possess strong leadership skills, technical knowledge related to quality assurance, and a commitment to fostering a culture of quality and inclusion within the organization. **

Job Summary

  • This role leads the manufacturing site to ensure compliance with customer requirements and the overarching Integer Quality Management System.
  • The position requires managing the entire local quality system including CAPA, complaint handling, design control, and supplier audits while adhering to FDA regulations.
  • Employees receive a comprehensive benefits package including medical, dental, vision, 401(k) matching, and immediate eligibility for paid time off.

Matching Summary

Match Score: 75

** Integer is seeking a Senior Manager of Quality with extensive experience in manufacturing and quality management systems to lead teams and ensure compliance with regulatory requirements. The ideal candidate will possess strong leadership skills, technical knowledge related to quality assurance, and a commitment to fostering a culture of quality and inclusion within the organization. **

Salary

Base: $150,000 - $220,220; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, disability, life insurance, 401(k) match

Skills & Requirements

Must-have

  • 8+ years manufacturing experience
  • ISO 13485 and FDA 21CFR820 knowledge
  • Root cause analysis and CAPA leadership
  • Team supervision and development
  • Supplier quality audit experience

Nice-to-have

  • Six Sigma Green Belt certification
  • ASQ Certified Manager of Quality
  • EU MDR regulatory knowledge
  • Hoshin planning strategic alignment
  • Diverse and inclusive culture champion

Key Requirements

  • Bachelor's degree in engineering or related technical field
  • Master's degree preferred
  • Prior supervisory or leadership experience required
  • Experience with Test Method development and validation protocols
  • Auditing experience with ISO standards

Work Rights

Not specified

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