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Senior Quality Assurance Manager

Job description

Senior Quality Assurance Manager

Job Responsibilities:

  • Manage and maintenance of the Health Quality System in full compliance with ISO 13485 and FDA QSR
  • Plan, recruit, develop and manage the talents for the Quality team and the Quality Inspection Team
  • Lead Quality Assurance activities, including but not limited to internal and external audits, complaint handling, supplier management evaluation, NCMRs, CAPAs, management reviews, product release and document control activities
  • Develop and Manage the Non-conforming Materials Review (NCMR)/ Deviationsprogram in collaboration with Operations to ensure timely reporting, analysis, and resolution of non-conforming material/ product incidences
  • Conduct supplier evaluation and audit
  • Develops, reviews and approves validation and calibration master plan
  • Interface and support audits by external regulatory bodies and follow-up activities to ensure the credentials
  • Other duties/ activities may be necessary to support departmental or company goals

 Job Requirements

  • 7-10 years quality assurance/engineering experience in the Medical Device industry. Minimum of five years managerial experience required
  • BS in life sciences, Engineering or equivalent
  • Ability to motivate and influence people
  • Organizing, planning, and problem-solving skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
  • Good statistical and numerical ability
  • Knowledge of FDA and ISO regulatory requirements and guidelines related to medical devices

  

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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