Manager, Global Quality Systems

Confluent Medical Technologies

Costa Rica
Not specified (potentially hybrid or onsite based on requirements).
7+ years process validation experience
3+ years leadership experience
Iso 13485 and fda 21 cfr part 820 knowledge
Confluent Medical Technologies is seeking a Manager for their Global Quality Systems in Costa Rica. The role involves overseeing quality systems activities, including training, supplier management, and compliance guidance, with a focus on maintaining high standards in the medical device industry

Job Summary

  • The role oversees Quality Systems activities at Confluent Medical, including Training, Supplier Management, customer audits, and Document Control.
  • Candidates must have 7+ years of experience in Process Validation within a regulated medical device industry with strong statistical knowledge.
  • This position requires approximately 25% travel to the U.S. to support global operations and cross-functional problem resolution.

Matching Summary

Match Score: 85

Confluent Medical Technologies is seeking a Manager for their Global Quality Systems in Costa Rica. The role involves overseeing quality systems activities, including training, supplier management, and compliance guidance, with a focus on maintaining high standards in the medical device industry.

Skills & Requirements

Must-have

  • 7+ years process validation experience
  • 3+ years leadership experience
  • ISO 13485 and FDA 21 CFR Part 820 knowledge
  • Lean manufacturing and Six Sigma expertise
  • Global multi-site quality system management

Nice-to-have

  • Certified Lead Auditor ISO 13485
  • Digital QMS platform implementation experience
  • Strong stakeholder management skills
  • Change management initiative drive
  • Advanced English proficiency B2+

Key Requirements

  • Bachelor's degree in Engineering or Life Sciences (Master's preferred)
  • Minimum 7 years Process Validation experience in medical devices
  • Minimum 3 years people management experience
  • Advanced English proficiency (B2+)

Work Rights

Not specified

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