Senior Manager, Quality

Integer

Base salary not specified; cash-based incentive pr...
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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 quality management systems in a manufacturing environment, ensuring compliance with FDA regulations and ISO standards. The ideal candidate should have significant experience in quality management, including leadership experience, and possess relevant certifications. **

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 quality audits.
  • Candidates must possess at least 8 years of manufacturing experience with ISO standards governance and prior supervisory leadership.

Matching Summary

Match Score: 75

** Integer is seeking a Senior Manager of Quality to lead quality management systems in a manufacturing environment, ensuring compliance with FDA regulations and ISO standards. The ideal candidate should have significant experience in quality management, including leadership experience, and possess relevant certifications. **

Salary

Base salary not specified; Cash-based incentive program available; Comprehensive benefits including medical, dental, vision, 401(k) match, and paid time off

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
  • Team leadership and development
  • Supplier quality audits

Nice-to-have

  • Six Sigma Green Belt certification
  • ASQ Certified Manager of Quality
  • Hoshin planning experience
  • Inclusive work environment champion
  • Cross-functional consensus building
  • Continuous improvement mindset
  • Strategic vision alignment

Key Requirements

  • Bachelor's degree in engineering or related field
  • Master's degree preferred
  • Minimum 8 years manufacturing experience
  • Prior supervisory or leadership experience
  • Knowledge of EU MDR and GMP
  • Auditing experience required
  • U.S. Applicants only (Equal Opportunity Employer)

Work Rights

Not specified

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