Senior Manager, Quality

Integer

Base salary not specified; cash-based incentive pr...
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Iso 13485 and iso 9001 compliance
Fda regulations 21cfr820 knowledge
Root cause analysis and capa leadership
** Integer is seeking a Senior Manager of Quality to lead quality management initiatives in a manufacturing environment, ensuring compliance with quality systems and regulations while fostering a culture of excellence and teamwork. The ideal candidate will possess extensive experience in quality management within the medical device industry, including leadership skills and specialized knowledge of quality systems. **

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.
  • The company offers a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and a 401(k) plan with company matching contributions.

Matching Summary

Match Score: 75

** Integer is seeking a Senior Manager of Quality to lead quality management initiatives in a manufacturing environment, ensuring compliance with quality systems and regulations while fostering a culture of excellence and teamwork. The ideal candidate will possess extensive experience in quality management within the medical device industry, including leadership skills and specialized knowledge of quality systems. **

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

  • ISO 13485 and ISO 9001 compliance
  • FDA regulations 21CFR820 knowledge
  • Root cause analysis and CAPA leadership
  • Supplier quality audits experience
  • Design control and validation protocols
  • Team leadership in manufacturing setting

Nice-to-have

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

Key Requirements

  • Bachelor's degree in engineering or related technical field
  • Minimum 8 years of manufacturing environment experience
  • Prior supervisory or leadership experience required
  • Knowledge of EU MDR and Good Documentation Practices
  • Experience with Test Method development and risk assessments

Work Rights

Not specified

Tailored Resume

Cover Letter