Sr. Quality Manager

Integer

8+ years manufacturing experience
Iso 13485 and iso 9001 knowledge
Fda 21 cfr 820 regulations
This role leads the manufacturing site to ensure compliance with customer requirements and the overarching Integer Quality Management System

Job Summary

  • This role leads the manufacturing site to ensure compliance with customer requirements and the overarching Integer Quality Management System.
  • The manager is responsible for the entire local quality system including CAPA, complaint handling, design control, and supplier quality audits.
  • Candidates must possess at least 8 years of experience in a manufacturing environment with ISO standards governance and prior supervisory experience.

Matching Summary

This role leads the manufacturing site to ensure compliance with customer requirements and the overarching Integer Quality Management System.

Skills & Requirements

Must-have

  • 8+ years manufacturing experience
  • ISO 13485 and ISO 9001 knowledge
  • FDA 21 CFR 820 regulations
  • Root cause analysis expertise
  • CAPA and complaint handling
  • Supplier quality audits
  • Team leadership and development

Nice-to-have

  • Six Sigma Green Belt certification
  • ASQ Certified Manager of Quality
  • Master's degree in engineering
  • EU MDR experience
  • Hoshin planning participation
  • Diverse and inclusive culture champion
  • Fast-paced decision making

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter