Sr. Quality Manager

486

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8+ years manufacturing experience
Iso 13485 and fda 21cfr820 knowledge
Root cause analysis and capa leadership
** Integer is seeking a Sr. Quality Manager to lead quality management efforts at their manufacturing sites, ensuring compliance with regulatory standards and driving continuous improvement. The ideal candidate will have significant experience in a manufacturing environment, particularly with ISO standards, and demonstrate strong leadership skills. **

Job Summary

  • The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they meet and continue to 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 while establishing a culture of quality across the site.
  • This role requires specialized knowledge of quality system regulations such as EU MDR, ISO 13485, ISO 9001, and Good Manufacturing Practices along with auditing experience.

Matching Summary

Match Score: 75

** Integer is seeking a Sr. Quality Manager to lead quality management efforts at their manufacturing sites, ensuring compliance with regulatory standards and driving continuous improvement. The ideal candidate will have significant experience in a manufacturing environment, particularly with ISO standards, and demonstrate strong leadership skills. **

Skills & Requirements

Must-have

  • 8+ years manufacturing experience
  • ISO 13485 and FDA 21CFR820 knowledge
  • Root cause analysis and CAPA leadership
  • Supplier quality audit experience
  • Team leadership and development
  • Design control and validation protocols

Nice-to-have

  • Six Sigma Green Belt certification
  • ASQ Certified Manager of Quality
  • EU MDR regulatory knowledge
  • Hoshin plan strategic alignment
  • Diverse and inclusive culture champion
  • Fast-paced decision making ability

Key Requirements

  • Bachelor's degree in engineering or related technical field
  • Minimum 8 years experience in manufacturing environment
  • Prior supervisory or leadership experience required
  • Knowledge of ISO standards governance and regulatory compliance
  • Experience with Test Method development and risk assessments

Work Rights

Not specified

Tailored Resume

Cover Letter