Role: Quality Engineer
An excellent opportunity has arisen for a Quality Engineer to join a large Clare based multinational medical device company. This employer of choice offers fantastic career progression as well as very attractive salary & benefits package.
- Co-ordinate the Manufacturing Non-conformance process (NC) for all BCII Production areas ensuring compliance to Quality and Regulatory Standards
- Participate in cross functional teams providing Quality guidance and support in the determination of appropriate NC root cause analysis and implementation of effective corrective actions.
- Provide guidance and support to all departments ensuring Good Manufacturing Practices (GMP) and Quality System Regulations are complied with during the production of product.
- Initiate/review/approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices
- Provide Quality expertise during investigations
- Ensure quality issues are communicated to the management team such that they are aware of any potential problems or opportunities
- Perform CAPA (corrective and preventive action) activities and document in the Global CAPA system if required.
- B.Sc in chemistry, biochemistry, engineering or other relevant technical field
- 3 years experience in Quality Assurance in a FDA regulated industry
- Effective interpersonal and verbal/written communication skills