LSC have a great contract opportunity for a Senior Quality Engineer to join a Galway based medical device company.
If you have 5 years' experience within Medical Device and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Responsible for ensuring Design control and Risk Management activities.
- Manage and maintain the records related to design control projects.
- Provide input into the generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports.
- Provide input and review to protocols and reports for sterilization, biocompatibility and packaging validations.
- Co-ordination of timely review and approval of all details in R&D batch sterilization records as meeting the requirements of the cycle validated.
- Co-ordination of timely review and approval of production records and sterilization records of product manufactured during the design control process to facilitate timely approval of Design protocols and reports.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum education of degree in a technical field is preferred.
- Minimum 5 years' experience in the medical device industry and/or IVD/pharmaceutical, with at least three years in a position with direct responsibility for QMS processes/sub-processes.
- Demonstrated knowledge of the application of the principles, concepts and practices of design control, sterilization, and Quality Assurance processes.
- Experience in preparation, participation, and response to external agency inspections e.g. FDA and Notified Body Inspections
- Working knowledge of 21 CFR 820, ISO13485 with familiarity of other foreign medical device quality system requirements
Note that this is a contract position and requires an Irish/ EU passport, Stamp 4/ Stamp 1G visa to apply.
Apply via this advert or contact Gráinne Hodnett at 021 4777 329 if you have any more questions about this opportunity!
