Program Manager

bluev.xyz

8-10 years project management experience
Medical device manufacturing environment
Product and equipment transfer leadership
The role involves building and managing an integrated Master Transfer Plan spanning sending and receiving sites for medical device products

Job Summary

  • The role involves building and managing an integrated Master Transfer Plan spanning sending and receiving sites for medical device products.
  • Candidates must ensure all transfer deliverables satisfy strict ISO 13485 and FDA 21 CFR 820 regulatory requirements.
  • Success is measured by completing product transfers within agreed timelines while achieving zero major non-conformances during audits.

Matching Summary

The role involves building and managing an integrated Master Transfer Plan spanning sending and receiving sites for medical device products.

Skills & Requirements

Must-have

  • 8-10 years project management experience
  • Medical device manufacturing environment
  • Product and equipment transfer leadership
  • ISO 13485 and FDA 21 CFR 820 compliance
  • Process validation URS IQ OQ PQ protocols
  • Cross-functional stakeholder management

Nice-to-have

  • Lean Six Sigma credentials
  • PMP or Prince2 certification
  • Strong coaching abilities
  • International travel up to 60%
  • Experience with cleanroom operations

Key Requirements

  • Bachelor's degree in engineering or Project Management
  • Master's degree preferred
  • Minimum 8-10 years of relevant experience
  • Proficiency with MS Project or Smartsheet
  • Knowledge of GMP and EHS standards

Work Rights

Not specified

Tailored Resume

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