Quality Systems Specialist

Posted 09 September 2022
Job type Permanent
Contact NameEugene O'Rourke

Job description

Our client, a reputable and growing medical devices company is currently seeking a Quality Systems Specialist to join their team at their state-of-the-art manufacturing facility in Co. Roscommon.

As a Quality Systems Specialist, you will report directly to the Quality Manager on site and will be responsible for providing quality systems support to all production processes. You will ensure quality standards are maintained and will play an integral role in the implementation and compliance of the site’s quality management program.


This is a permanent position with an excellent salary & package.


Your new job

Key duties & responsibilities:

· Record, investigate, and provide a resolution for product complaints, product problems, or safety issues. 

· Coordinate and maintain the Corrective Action program.

· Regularly run complaint, CAPA, NCR, and continuous improvement monitoring.

· Generate KPI data around Complaint, CAPA, NCR, and continuous improvement

· Ensure that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.

· Ensure all environmental metrics are maintained up to date

· Provide support to Regulatory Affairs department with all international country submissions.

· Help to manage and maintain all RA documentation.

· Support the preparation of change notifications/Validation protocols and Reports.

· Support sterilisation validation / revalidation.

What are we looking for?

  • A minimum of three years’ experience in a Quality role in the medical devices or pharmaceutical industry.
  • A degree in Engineering, Science, or Quality.
  • Experience of working in a fast-paced and highly regulated manufacturing environment.
  • Familiarity with ISO quality systems (ISO13485 – 21 CFR 820)
  • Excellent stakeholder management skills, both internal and external.
  • Ability to present an independent opinion
  • Strong communication and interpersonal skills - communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.
  • Ability to prioritise tasks and workload effectively and consistently meet deadlines.
  • Possess excellent attention to detail, maintaining high standards despite tight deadlines.
  • Excellent problem-solving skills (using recognized tools).
  • Strong IT skills - Change control management; design, process, and system.


Apply for this job now with a Word version of your CV or get in touch with Oliver at oliver@matrixrecruitment.ie


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