Sr. Quality Manager

636

Not specified (assumed to be onsite or hybrid based on industry norms).
8+ years manufacturing experience
Iso 13485 and fda 21cfr820 knowledge
Root cause analysis and capa leadership
Integer is seeking a Senior Quality Manager to lead quality management at their manufacturing sites, ensuring compliance with quality systems while fostering a culture of quality and teamwork. The ideal candidate will have extensive experience in manufacturing quality systems and regulatory compliance, along with strong leadership skills

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 to establish a culture of quality across the site.
  • This role requires specialized knowledge of quality system regulations such as ISO 13485, ISO 9001, and Good Manufacturing Practices along with auditing experience.

Matching Summary

Match Score: 85

Integer is seeking a Senior Quality Manager to lead quality management at their manufacturing sites, ensuring compliance with quality systems while fostering a culture of quality and teamwork. The ideal candidate will have extensive experience in manufacturing quality systems and regulatory compliance, along with strong leadership skills.

Skills & Requirements

Must-have

  • 8+ years manufacturing experience
  • ISO 13485 and FDA 21CFR820 knowledge
  • Root cause analysis and CAPA leadership
  • Team leadership and development
  • Supplier quality audits and internal QMS audits

Nice-to-have

  • Six Sigma Green Belt certification
  • ASQ Certified Manager of Quality
  • Experience with EU MDR regulations
  • Hoshin planning and strategic alignment
  • Diverse and inclusive work environment promotion

Key Requirements

  • Bachelor's degree in engineering or related technical field
  • Master's degree preferred
  • Minimum 8 years of manufacturing experience
  • Prior supervisory or leadership experience required
  • Knowledge of EU MDR, ISO 13485, ISO 9001, 21CFR820

Work Rights

Not specified

Tailored Resume

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