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Employer Sigmar Recruitment
Job Title Senior QA Operations Engineer (6 Month C

Provide Quality Assurance support to the stent Supplier, to ensure that manufacturing is performed in a manner that assures product quality and meets regulatory requirements. Travelling between Galway officer and Hamburg (Stent Supplier)


  • Manage the relationship with the stent manufacturer to ensure that our product quality requirements are achieved
  • Closely oversee the stent supplier QMS activities, as they relate to our product, to ensure that our related compliance activities are performed in line with applicable regulatory requirements
  • Lead the activities associated with preparing the stent supplier to achieve a successful FDA inspection. Providing status updates to our Management
  • Review supplier changes ensuring product impact is assessed
  • Support Risk Management activities as required
  • Review and contribute to process validation activities of the stent Supplier
  • Drive SCAR, CAPA and NCR activities to closure with the stent Supplier
  • Drive stent supplier audit NC’s, ensuring they are closed out in a thorough and timely manner
  • Develop and mentor other team members
Support Activities

  • Support the Finished Device Manufacturing Subcontractor to ensure that our product quality requirements are achieved
  • Support the Complaint Coordinator in evaluation/investigation of product complaints
  • Support R&D and Design Assurance in development activities linked to the principal responsibilities above
  • Auditing of subcontractors and suppliers
  • Perform lot review and lot release activities

  • Educated to a Minimum Diploma Level in an Engineering, Science or Quality Assurance discipline

  • No specific training requirements. However, Training / Qualifications in CAPA, Auditing, Risk Management and Quality System experience is highly desirable

  • A minimum of 7 years’ manufacturing quality experience in a medical device manufacturing environment, is required
  • Excellent attention to detail, communication skills, problem solving skills, people and team working skills is required
  • Capable of working under minimal supervision
  • FDA inspection experience is desirable
  • Experience of managing suppliers is desirable.
  • Experience in process validation and risk management activities is required.
  • Auditing experience, both internally and of suppliers is desirable.
Regulatory / Quality Requirements:

  • ISO 13485
  • 21 CFR 820
  • ISO 14155
  • 21 CFR Parts 50, 54, 56, 812
  • MDD
  • Quality management system experience
  • CAPA
  • Auditing
  • Risk Management (including FMECA) (ISO 14971)
Relationships – Internal:

  • Interaction with QA, R&D and Operations at all organizational levels daily.
  • Routine contact with all functions and levels of personnel within our Company
Relationships – External:

  • The Senior Quality Engineer will be working with the stent supplier daily. Therefore, it will involve a minimum of 50% time working at the stent supplier facility
  • The Senior Quality Engineer will need to be assertive in ensuring that our product quality and compliance needs are satisfied, while simultaneously fostering good working relationships and a spirit of collaboration

To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E:

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

This job originally appeared on
Location Galway
Date Added 5 days ago
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