Our client, a multinational medical device manufacturing company based in Athlone, is hiring for an initial 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 preferable.
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.
What's 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 information on this position please contact Gillian Nicholson
gillian.nicholson@collinsmcnicholas.ie
090 6450665