Quality Engineer
- Co Westmeath
- Permanent
- Full-time
- 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.
- 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
- Global medical Device company
- Hybrid working model
- Career advancement opportunities
- Flexibility to work with different teams within other manufacturing units.