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 21cfr820 regulatory compliance
** Integer is seeking a Senior Manager of Quality to lead manufacturing sites and ensure compliance with quality management systems. The ideal candidate will have significant experience in manufacturing quality assurance and leadership, driving process improvements while fostering a culture of quality and teamwork. **

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, establishing a culture of quality across the site.
  • Our total rewards program includes base salary, a cash-based incentive program, comprehensive medical/dental/vision benefits, and immediate eligibility for a 401(k) plan with company matching.

Matching Summary

Match Score: 75

** Integer is seeking a Senior Manager of Quality to lead manufacturing sites and ensure compliance with quality management systems. The ideal candidate will have significant experience in manufacturing quality assurance and leadership, driving process improvements while fostering a culture of quality and teamwork. **

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 and CAPA leadership
  • Team supervision and development skills
  • Supplier quality audit experience

Nice-to-have

  • Six Sigma Green Belt certification
  • ASQ Certified Manager of Quality
  • EU MDR regulatory knowledge
  • Hoshin plan strategic alignment
  • Diverse and inclusive culture champion
  • Cross-functional consensus building

Key Requirements

  • Bachelor's degree in engineering or related technical field
  • Master's degree preferred
  • Minimum 8 years in manufacturing with ISO/regulatory governance
  • Prior supervisory or leadership experience required
  • Knowledge of EU MDR, ISO 13485, ISO 9001, 21CFR820
  • Experience with Test Method development and Validation Protocols

Work Rights

Not specified

Tailored Resume

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