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