Our client, a multinational medical device manufacturing company based in Athlone, is hiring for an inital 12-month contract for the role of Quality Engineer. The role is offering a hybrid-based position. The position will be based at their manufacturing site as part of the Manufacturing Quality team
Purpose of Job:
Responsible for initiating and performing defined quality activities leading to new or improved processes or systems
Key Responsibilities:
* Initiating, reviewing, and approving change controls
* Ensuring compliance is maintained for Product Manufacturing, Packaging and Labeling.
* Developing a strategy and implementing appropriate sampling methods
* Write up and review of CAPAs, NC/NCMRs and SCARs to address compliance issues and providing guidance to suppliers and engineering.
* Performing Internal and Supplier Audits.
* Supporting and participating in external regulatory body audits, e.g., ISO and FDA
* Complying with all relevant training required and adhering to relevant associated documentation.
* Abiding to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
* Following strict adherence to the requirements of CGMP.
Experience Required:
* Degree level qualification in Quality, Science or Engineering is required
* Minimum Three (3) years experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments is preferrable.
* Medical device change control implementation
* Strong computer skills (MS Excel, PowerPoint, Word etc.)
* Familiarity with statistical tools such as Pareto charts and trend charts.
* Familiarity with FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.
* Experience with problem solving techniques
* Ability to effectively communicate technical information, both verbally and in writing, to both non-technical and technical associates.
* Ability to work within a fast paced team environment
Whats in it for you?
* Global medical Device company
* Hybrid working model
* Career advancement opportunities
* Flexibility to work with different teams within other manufacturing units.
For further informaiton on this position please contact Gillian Nicholson at gillian.nicholson@collinsmcnicholas.ie or call Gillian directly on 090 6450665
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