Quality Engineer NPI
The New Product & Process Introduction Quality Engineer will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls for product and process projects in Integer Galway as well as providing backup support for quality engineers.
- Developing and maintaining quality world class systems related to the manufacture of guide wires while developing employee efficiencies.
- Responsible for all quality aspects of projects and areas of support including:
- Engineering Change Order (ECO).
- Corrective & Preventative Action (CAPA).
- Request for Technical assistance (RTA)
- Non Conformance Requests (NCR)
- Failure Mode Effect Analysis (FMEA).
- Responsible for the successful completion of all quality aspects of customer FARFs
- Playing a role in the plant annual objectives.
- Ensure continued compliance with all Regulatory Standards. This includes:
- ISO 13485
- FDA QSR
- Ensuring continued compliance with DMR
- Develop and maintain a program ensuring only correctly validated equipment is used in production process. This will include:
- Participation in validation protocol development
- Overseeing completion of validation or validation samples
- Supporting the manufacturing engineering function to ensure compliance to related element of quality system.
- Ensure the company behavioural standards are adhered to
- Preparation of information for PMR and Management Review meetings.
- Ensuring backup and notification for any absences within the group, and being available and flexible to provide cover for absences as required.
- Engineering or science Degree preferably with Quality Engineering included.
- 1-3 years experience in a similar position
- Experience in Minitab and Oracle would be preferable.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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