Senior Manager, Quality

576

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 regulatory compliance
** Integer is seeking a Senior Manager of Quality to lead their manufacturing site(s) in ensuring compliance with quality management systems while promoting a culture of quality and continuous improvement. The ideal candidate should have a strong background in manufacturing quality, regulatory compliance, and leadership, with experience in ISO standards and quality 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 entirety of the 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 experience.

Matching Summary

Match Score: 75

** Integer is seeking a Senior Manager of Quality to lead their manufacturing site(s) in ensuring compliance with quality management systems while promoting a culture of quality and continuous improvement. The ideal candidate should have a strong background in manufacturing quality, regulatory compliance, and leadership, with experience in ISO standards and quality certifications. **

Salary

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

Skills & Requirements

Must-have

  • 8+ years manufacturing experience
  • ISO 13485 and ISO 9001 knowledge
  • FDA 21 CFR 820 regulatory compliance
  • Root cause analysis and CAPA leadership
  • Team supervision and development
  • Supplier quality audits
  • Design control and validation protocols

Nice-to-have

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

Key Requirements

  • Bachelor's degree in engineering or related technical field
  • Master's degree preferred
  • Minimum 8 years in manufacturing environment
  • Prior supervisory or leadership experience required
  • Knowledge of EU MDR, ISO 13485, ISO 9001, 21CFR820
  • Auditing experience required
  • U.S. Applicants only (Equal Opportunity Employer)

Work Rights

Not specified

Tailored Resume

Cover Letter