Quality And Compliance Manager

Carl Zeiss Pty Ltd

Exeter, NH, US
**
5+ years senior qa in medical device or pharma
Iso13485 and fda regulatory framework expertise
Experience managing distribution of disposable devices
** The Quality and Compliance Manager position at Carl Zeiss Pty Ltd involves leading quality assurance and compliance across three U.S. entities in the ophthalmic medical device industry. The role requires strategic oversight of quality management systems, regulatory compliance, and continuous improvement initiatives. **

Job Summary

  • This role provides strategic and operational quality leadership across three US entities within the Zeiss family of companies.
  • The successful candidate will act as the primary liaison between US Quality teams and Global Quality to ensure alignment with federal regulations.
  • Employees receive comprehensive benefits including 90% employer-paid medical, 100% employer-paid dental, and full life insurance coverage.

Matching Summary

Match Score: 75

** The Quality and Compliance Manager position at Carl Zeiss Pty Ltd involves leading quality assurance and compliance across three U.S. entities in the ophthalmic medical device industry. The role requires strategic oversight of quality management systems, regulatory compliance, and continuous improvement initiatives. **

Skills & Requirements

Must-have

  • 5+ years senior QA in medical device or pharma
  • ISO13485 and FDA regulatory framework expertise
  • Experience managing distribution of disposable devices
  • Leading FDA and Notified Body inspections
  • Managing multi-site quality systems harmonization

Nice-to-have

  • Six Sigma or Lean certification
  • Experience with combination products
  • Proactive problem-solving and creative thinking
  • Ability to work independently in global teams
  • Strong ethical standards and integrity

Key Requirements

  • Minimum Bachelor degree in engineering
  • Minimum 5 years in senior QA role
  • Qualification in Quality Assurance (e.g., Six Sigma, ASQ)
  • Experience managing FDA regulated activities
  • People management experience required

Work Rights

Not specified

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