Quality System Engineer with strong working knowledge of ISO13485 and FDA QSR requirements required by medical devices multinational in Galway for 12 month fixed term contract.

Key Responsibilities:

  • Actively stays current with external and internal quality system standards.
  • Providing Quality Systems support for site.
  • Support QMS integration activity across the site.
  • Responsible for coordinating and managing all external audits.
  • Responsible for managing the site internal audit process.
  • Responsible for managing the site internal CAPA process.
  • Approvals as defined on Oracle.
  • Identifies deficiencies in quality systems and defines systematic corrective actions.
  • Develops effective quality metrics and communicates the results.
  • Ensure compliance and drive improvements in QS processes.
  • Assists in the preparation and maintenance of records.
  • Completed monthly Manufacturing Training Report.

 

Requirements: 

  • BSc. in Quality Assurance or Science/Engineering
  • 3-5 years’ experience as a Quality Engineer within the Medical Devices/Pharmaceutical industry
  • Strong working knowledge of ISO13485 and FDA QSR requirements
  • Regulatory experience / knowledge
  • Proven ability to influence
  • Excellent attention to detail and report writing skills
  • Trained Auditor ideally lead auditor training and/or experience

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

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