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Quality Systems Compliance Specialist

Job description

Quality Systems Compliance Specialist

The role requires a minimum of 3 years quality management systems experience in the medical device industry and the candidate must exhibit excellent problem solving and an innovative rational mindset to ensure implementation of advanced, efficient appropriate quality management practices.

Responsibilities:

  • Support and coordinate improvement programs including conducting CAPA analysis to determine root cause and complete problem resolution
  • Coordinate the internal audit program and ensure that Internal Audits are completed
  • Support the preparation and conduct of External Audits
  • Support compliance and continuous improvement QMS related projects
  • Support interactions with certification bodies in relation to QMS auditing, certification, and changes.
  • Support processes for monitoring and measurement of processes including generation of routine QMS performance reports, objectives and KPIs

Experience:

  • Minimum 5 years’ experience in a relevant role in the medical device industry
  • Degree in Quality Assurance, Quality Engineering or similar qualifications
  • Broad experience of Medical Device Quality Management Systems,
  • Experience in CAPA system management,
  • Experience in Complaint handling systems,
  • A working knowledge of FDA requirements and managing regulatory body audits,
  • Proven ability of working in a cross-functional team environment,
  • Knowledge and practical experience with the use of statistical techniques,
  • Training and experience in auditing (internal auditing, supplier auditing or similar),
  • Detail oriented with focus on implementing efficient systems for QMS Compliance.

 

To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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