Sr. Quality Manager

Integer

**
8+ years manufacturing experience
Iso 13485 and iso 9001 knowledge
Fda regulations and 21cfr820 expertise
** Integer is seeking a Sr. Quality Manager to lead quality assurance efforts within its manufacturing sites, ensuring compliance with quality management systems while fostering a culture of quality and teamwork. The ideal candidate will have significant experience in manufacturing environments, strong leadership skills, and a solid understanding of quality systems and regulations. **

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 the associated quality management system policies and procedures.
  • You will provide leadership for a team of Quality function professionals, including any combination of Quality Supervisors, Quality Engineers, and individual performers.
  • You are responsible for the entirety of the local quality management system which includes Management Review, CAPA, Complaint Handling, Document Change Management, Design Control, Production control, internal and Customer nonconformance management, Supplier Quality Audits, and Internal QMS Audits.

Matching Summary

Match Score: 75

** Integer is seeking a Sr. Quality Manager to lead quality assurance efforts within its manufacturing sites, ensuring compliance with quality management systems while fostering a culture of quality and teamwork. The ideal candidate will have significant experience in manufacturing environments, strong leadership skills, and a solid understanding of quality systems and regulations. **

Skills & Requirements

Must-have

  • 8+ years manufacturing experience
  • ISO 13485 and ISO 9001 knowledge
  • FDA regulations and 21CFR820 expertise
  • Team leadership and development skills
  • Root cause analysis and CAPA management

Nice-to-have

  • Six Sigma Green Belt certification
  • ASQ Certified Manager of Quality
  • Bachelor's degree in engineering
  • Master's degree preferred
  • Diverse and inclusive work environment

Key Requirements

  • Minimum bachelor's degree in engineering or related technical field
  • At least 8 years of experience in a manufacturing environment
  • Prior supervisory or leadership experience required
  • Specialized knowledge of EU MDR, ISO 13485, ISO 9001, 21CFR820
  • Experience with Test Method development and risk assessments

Work Rights

Not specified

Tailored Resume

Cover Letter