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Quality Engineer Manager Medical Device 65k

Job description

Medical device manufacturer in Dublin South is looking to hire Quality Engineering Manager to oversee their Medical Device Engineering department functions in product production facility, including Supplier Quality Assurance. You will have an exciting opportunity to develop a growing team - with expansion plans for 2019!

The ideal candidate will have experience in quality engineering function within medical device GMP manufacturing facilities.

Job Responsibilities

  • Ensure customer and product specification quality adherence.
  • Support new component introduction to production process.
  • Manage customer documentation within the quality manufacturing function, such as Quality Agreements andSpeciacations.
  • Managing and approving quality documentation like QQS, CAPAs, and Defect Monitoring Documents.
  • Drive investigations into material quality issues, as well as product quality non-conformances via QA investigative methodologies like RCA and raising CAPAs.
  • Support SCAR process as an when needed.
  • PArticipate in the internal audits.
  • PArticipate in Validation procedures as required by the business needs.
  • BAtch record review and disposition.
  • Participate in LEAN systems implementation.
  • Reporting of risk KPIs like PPK's,CPK's, and Cost of Quality

Job Qualification Requirements

  • Degree in Science/Engineering or related fields.
  • Experience in Med Dev GMP Manufacturing.
  • Knowledge of ISO13485 specification and conformance requirements for manufacturing facilities.
  • Experience in CFR regulatory framework i.e. 21 CFR part 820 (Advantage, but not a hard requirement).

If you are exploring Pharmaceutical Med Dev, Biologics or Engineering roles, contact Andrius at 014744692 or email andrius@sigmar.ie to organize a confidential call.

Should you be interested in this role or would like to query further detail don't hesitate to get in touch.

 

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