Quality Specialist

Quality Assurance Specialist- Medical Devices

Our client within the medical device industry are looking for a Quality Assurance Specialist to join their distribution facility team in Waterford. They are open to looking at someone on a full or part time basis.

Key Responsibilities:

  • Perform all activities assigned to the Quality Assurance Function, including but not limited to Management Review, CAPA, Internal and External Audits, Product Complaints, Document Control, record Retention, Training, Calibration, Label Approval, and Inspection – serving as the site lead for Quality.
  • Ability to review current Quality Management System to ensure compliance and effectiveness for the site.
  • Maintain compliance to applicable quality and regulatory requirements. Maintain compliance to ISO13485 and sustained a certified quality system.
  • Set standards and partner with the warehouse team to ensure compliance and provide appropriate direction.
  • Perform all activities assigned to the Quality Control Function Monitor, including but not limited to processes related to product quality, handle the non-conforming product process assuring segregation and disposition of suspect product, inspection and release, warehousing controls, receiving inspection, and other activities associated with product acceptance.
  • Oversee Manufacturer Management and Handle QA Receiving process.
  • Support procedure pack assembly processes and controls. This includes:
  • Assure all aspects of the kitting or packaging process are in conformance to process requirements
  • Verify labelling for accuracy and conformance,
  • Inspect parts and assure all components of the packaged product are correct as per the production order and specification
  • Complete and maintain all applicable records (e.g., Device History Records).

Education and Experience:

  • Bachelor’s degree in a technical discipline.
  • Two to three years’ experience in a medical device regulated facility.
  • Preferred experience in ISO set up and standardization.
  • Basic understanding of both legal and scientific matters
  • Ability to grasp new concepts quickly and to assimilate and evaluate scientific data
  • Analytical and problem-solving skills
  • Strong written and oral communication skills
  • Attention to detail
  • IT skills, particularly in relation to using databases and familiarity with commercial software
  • The ability to work under pressure and to strict deadlines
  • The confidence to report to management
  • Team-working skills and the ability to lead and motivate others
  • Project-management skills
  • Integrity and a professional approach to work

Physical requirements:
Able to use a personal computer.  Able to bend, reach, and occasionally lift up to 30 lbs./ 14 kg.
Office and lab environment and occasional exposure to manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.


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Job Details

28 February 2024
Job ID: 9194

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