Senior Manager, Quality

Integer

Base salary not specified; cash-based incentive pr...
Not specified
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 manufacturing sites in ensuring compliance with quality management systems while fostering a culture of quality and continuous improvement. The ideal candidate should have extensive experience in manufacturing quality management, particularly in the medical device sector, along with strong leadership skills

Job Summary

  • This role leads the manufacturing site to ensure customer requirements are met while maintaining compliance with the Quality Management System.
  • The successful candidate will define and champion the evolution of local Quality Systems to standardize with the overarching Integer QMS.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching.

Matching Summary

Match Score: 85

Integer is seeking a Senior Manager of Quality to lead manufacturing sites in ensuring compliance with quality management systems while fostering a culture of quality and continuous improvement. The ideal candidate should have extensive experience in manufacturing quality management, particularly in the medical device sector, along with strong leadership skills.

Salary

Base salary not specified; Cash-based incentive program available; Comprehensive benefits 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 Certified Manager of Quality
  • EU MDR regulatory knowledge
  • Design control experience
  • FMEA and capability analysis
  • Hoshin plan 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 EU MDR and Good Documentation Practices
  • Auditing experience required

Work Rights

Not specified

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