Description
A leading medical device company dased in Galway have an immediate opening for a Senior Quality Engineer to joing their rapidly growing team.The successful candidate will work as part of a team to maintain high quality / performance standards on all products. Reporting to the Quality Manager, the position will be challenging and will require an ability to work with minimum supervision.
Major Accountabilities:
- Lead and drive QA initiatives across a range of value streams.
- Lead and coordinate preparing & on-going maintenance of FMEAs and Control Plans.
- Investigating root cause of quality issues and following through with timely and effective corrective actions to prevent re-occurrence.
- Strategically lead new product introduction from a QA perspective.
- Overall responsibility for production GMP standards and compliance, also including cleanroom requirements.
- Establishing inspection standards, plans, frequencies and test methods.
- Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements
- Develop strong links with customer organisations and other project stakeholders.
- Understanding of standard metrology good practice in measuring plastic micro size components
- Performing internal and external audits to ISO and FDA requirements.
- Supervision and direction of other Quality personnel.
- Other tasks as directed by the Quality Manager in line with company objectives.
- Any other duties assigned from time to time.
- Be responsible for Health & Safety within assigned areas
Requirements:
- Degree in Science or Engineering
- Minimum of 5yrs industry experience in a medical device-manufacturing environment.
- Understanding quality requirements of moulded and over-moulded medical devices and components; including measurement techniques, would be a distinct advantage.
- Strong working knowledge of FDA and ISO Quality systems for Medical device companies.
- Strong understanding of problem solving methodologies.
- Supervisory experience required
This is a really exciting time to be joining this company during a major growth phase.
If you are interested in this role please apply directly to this advert or contact Derek Sheridan on for further information.