Senior Manager, Quality

Integer

Base: not specified; bonus/equity: cash-based ince...
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8+ years manufacturing experience
Iso 13485 and iso 9001 knowledge
Fda 21 cfr 820 regulations
** Integer is seeking a Senior Manager of Quality to lead and enhance the quality management systems within its manufacturing sites, ensuring compliance with customer requirements and regulatory standards. The ideal candidate will have substantial experience in quality management, a background in ISO standards, and effective leadership skills to foster a culture of quality and continuous improvement. **

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 Quality Supervisors, Quality Engineers, and individual performers, fostering a culture where everyone owns quality.
  • Our total rewards program includes base salary, a cash-based incentive program, comprehensive benefits with immediate eligibility, and an annual allotment of paid time off.

Matching Summary

Match Score: 75

** Integer is seeking a Senior Manager of Quality to lead and enhance the quality management systems within its manufacturing sites, ensuring compliance with customer requirements and regulatory standards. The ideal candidate will have substantial experience in quality management, a background in ISO standards, and effective leadership skills to foster a culture of quality and continuous improvement. **

Salary

Base: Not specified; Bonus/Equity: Cash-based incentive program supporting pay-for-performance; Benefits: Comprehensive package including medical, dental, vision, 401(k) match, and 10 days holidays

Skills & Requirements

Must-have

  • 8+ years manufacturing experience
  • ISO 13485 and ISO 9001 knowledge
  • FDA 21 CFR 820 regulations
  • Root cause analysis expertise
  • CAPA and complaint handling
  • Supplier quality audits
  • Team leadership and development

Nice-to-have

  • Six Sigma Green Belt certification
  • ASQ Quality Auditor certification
  • EU MDR regulatory knowledge
  • Hoshin planning experience
  • Diverse and inclusive culture champion
  • Strategic vision alignment
  • Continuous improvement mindset

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
  • Experience with Test Method development and validation protocols

Work Rights

Not specified

Tailored Resume

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