Medical device manufacturer in Dublin is looking to hire Operational Quality Engineers to oversee their Quality and Validation functions in product production facility.
The ideal candidate will have 2 years experience in quality engineering function within medical device GMP manufacturing facilities.
- Ensure customer and product specification quality adherence.
- 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)
- Understanding of plastic product manufacturing.
If you are exploring Pharmaceutical Med Dev, Biologics or Engineering roles, contact Andrius at 014744692 or email firstname.lastname@example.org 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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