Quality And Compliance Manager

Carl Zeiss Pty Ltd

Exeter, NH, USA
On-site
Quality management system (qms) harmonization
Regulatory compliance for medical devices
Fda and iso13485 requirements
Carl Zeiss Pty Ltd is seeking a Quality and Compliance Manager for its Dutch Ophthalmic division in Exeter, NH. The ideal candidate will lead quality assurance efforts across multiple U.S. sites, ensuring compliance with regulatory standards in the medical device and pharmaceutical fields

Job Summary

  • Provides strategic and operational quality and compliance leadership across three US entities.
  • Ensures commercial and distribution activities comply with federal and state regulations for devices and pharmaceutical products.
  • Offers comprehensive benefits including 90% employer-paid medical and 100% employer-paid dental, life, STD, and LTD insurance.

Matching Summary

Match Score: 85

Carl Zeiss Pty Ltd is seeking a Quality and Compliance Manager for its Dutch Ophthalmic division in Exeter, NH. The ideal candidate will lead quality assurance efforts across multiple U.S. sites, ensuring compliance with regulatory standards in the medical device and pharmaceutical fields.

Skills & Requirements

Must-have

  • Quality Management System (QMS) harmonization
  • Regulatory compliance for medical devices
  • FDA and ISO13485 requirements
  • Management of quality and compliance teams
  • Continuous improvement of QMS processes

Nice-to-have

  • Strategic quality leadership
  • Collaboration with global quality teams
  • Open-minded for improvement opportunities

Key Requirements

  • Bachelor degree in engineering
  • Qualification in Quality Assurance
  • Minimum 5 years in senior QA role
  • Experience managing FDA/Notified Body inspections
  • Experience in people management

Work Rights

Not specified

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