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Senior Quality Assurance Specialist

2 weeks ago

Galway, Galway, Ireland beBeeEngineering Full time €60,000 - €80,000

Job Role:

About Us:

  • We are seeking an experienced Quality Assurance professional to join our team as a Quality Engineer.

Job Summary:

We are looking for a skilled Quality Engineer who can develop, implement and maintain quality assurance procedures. This role involves working closely with suppliers to ensure quality standards are met.

Main Responsibilities:

  • Develop, implement and maintain quality assurance procedures and methods for control of materials and finished goods.
  • Work closely with the operations team and suppliers to ensure quality standards are met and maintained.
  • Develop and execute product quality control plans, documents and procedures.
  • Provide input to risk analyses and Process Failure Mode Effect Analysis' (pFMEAs) including with suppliers.
  • Implement and enhance quality principles, gather and analyse quality data to support product/process improvement activities.
  • Oversee manufacturing related quality events in line with GMP and internal procedures, including process defects, CAPA, and complaint investigations.
  • Disposition non-conforming material and work with manufacturer and suppliers to implement corrective and preventive actions.
  • Provide quality guidance as an integral member of the operations team, influencing manufacturing activities.
  • Provide quality input into process validation activities.

Key Requirements:

  • Bachelor's Degree or equivalent.
  • Post-graduate qualification in Quality Assurance is desirable.
  • Minimum 3 years of experience in Quality Engineering or a related field within the medical device industry.
  • Proven experience working in a medical device manufacturing environment complying with Good Manufacturing Practices.