Director, Quality

Merrimack Manufacturing

Manchester, NH, USA
On-site
Quality management system implementation
Iso 13485:2016 certification maintenance
21 cfr 820 regulatory compliance
This position will help establish, mentor and lead our Quality Team and serve as the cornerstone for further developing this function

Job Summary

  • This position will help establish, mentor and lead our Quality Team and serve as the cornerstone for further developing this function.
  • The role involves improving and maintaining a quality assurance system that ensures customer safety is never compromised and attaining ISO 13485:2016 certification.
  • The Director will act as the primary interface on audits, lead supplier quality efforts, and continually seek opportunities to improve processes and business tools.

Matching Summary

This position will help establish, mentor and lead our Quality Team and serve as the cornerstone for further developing this function.

Skills & Requirements

Must-have

  • Quality management system implementation
  • ISO 13485:2016 certification maintenance
  • 21 CFR 820 regulatory compliance
  • FDA inspection leadership
  • Supplier quality performance monitoring
  • Quality assurance team leadership

Nice-to-have

  • Collaborative problem solving approach
  • Experience in startup environment
  • Intellectual curiosity in operations
  • Strong communication across roles

Key Requirements

  • 15+ years QMS implementation experience
  • 10+ years medical device industry experience
  • Experience with ISO 13485 and 21 CFR 820
  • Demonstrated FDA inspection leadership
  • Bachelor's degree or equivalent experience

Work Rights

Not specified

Tailored Resume

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