Job Description


Job description :
  • We are seeking a Senior Quality Engineer to support process development, manufacturing quality, and compliance for implantable cardiac and neuromodulation medical devices.
  • This role focuses on inspection optimization, process and test method validation, and continuous improvement within a regulated medical device manufacturing environment.
  • Roles & Responsibilities:
  • Lead Inspection Optimization projects (manual, automated, and semi-automated inspection)
  • Support equipment development, IQ/OQ/PQ, process characterization, and validation
  • Develop and execute Test Method Validation (TMV), including Gage R&R / MSA
  • Ensure compliance with FDA, ISO, and GMP quality requirements
  • Support CAPA, nonconformance investigations, change control, and risk management (pFMEA/dFMEA)
  • Drive quality metrics, scorecards, and continuous improvement initiatives
  • Collaborate...

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