Senior Quality Engineer
- Galway, Republic of Ireland
- Quality Assurance (QA)
My client are a medical device contract manufacturer, based in Galway. They provide a broad range of services to design, develop and deliver finished medical devices to market. Due to my client's acquisition by a multi-billion euro technology company, their site in Galway is going from strength to strength and is home to their global HQ. Due to this growth, they need an ambitious Senior Quality Engineer to join them. They are offering a really attractive salary and benefits package for the perfect candidate.
What will you be doing as a Senior Quality Engineer?
- Overall responsibility for production GMP standards and compliance.
- Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.
- Establishing inspection standards, plans, frequencies and test methods.
- Establishing and maintaining FMEA's.
- Preparing and updating Operations procedures and associated documentation.
- Reporting area of responsibility metrics.
- Supporting customer and surveillance accreditation audits.
- The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.
- Degree in Quality or Degree in Science / Engineering.
- Experience within a similar role as quality engineer.
- 3+yrs industry experience in a medical device-manufacturing or pharmaceutical environment
- Working knowledge of FDA/ISO/MDD Quality systems for Medical device companies.
- New product introduction and manufacturing process transfer experience would be a distinct advantage.
Please apply directly below if this sounds like the perfect role for you!
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