Senior Manager, Quality

Integer

Base salary not specified; cash-based incentive pr...
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Iso 13485 and iso 9001 compliance
Fda 21 cfr 820 regulations
Root cause analysis and capa management
** Integer is seeking a Senior Manager of Quality to lead quality management initiatives at their manufacturing sites, ensuring compliance with regulatory standards and fostering a culture of quality. The role involves building and developing quality teams, managing quality systems, and driving process improvements to enhance customer satisfaction. **

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 supervisors, engineers, and individual performers, while establishing a culture of quality across the site.
  • The company offers a comprehensive benefits package including immediate eligibility for 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 at their manufacturing sites, ensuring compliance with regulatory standards and fostering a culture of quality. The role involves building and developing quality teams, managing quality systems, and driving process improvements to enhance customer satisfaction. **

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

  • ISO 13485 and ISO 9001 compliance
  • FDA 21 CFR 820 regulations
  • Root cause analysis and CAPA management
  • Supplier quality audits and internal QMS audits
  • Team leadership and development of quality professionals
  • Design control and production control oversight

Nice-to-have

  • Six Sigma Green Belt certification
  • ASQ Certified Manager of Quality
  • Experience with EU MDR regulations
  • Strategic vision alignment with Hoshin plans
  • Fostering diverse and inclusive work culture
  • Proactive risk management in quality

Key Requirements

  • Bachelor's degree in engineering or related technical field
  • Master's degree preferred
  • Minimum 8 years experience in manufacturing environment
  • Prior supervisory or leadership experience required
  • Knowledge of Good Manufacturing Practices (GMP)
  • Auditing experience required

Work Rights

Not specified

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