Quality Engineer

Job Overview

Role: Quality Engineer
Location: Clare

The Company:
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.

Education/ Experience:

  • 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

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