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Senior Quality Systems Specialist

2 weeks ago

Galway, Galway, Ireland beBeeQualityEngineer Full time €60,000 - €102,000
Senior Quality Systems Engineer Role

Overview:
We are seeking a Senior Quality Systems Engineer to play a key role in the setup, implementation, and maintenance of our company's Quality Management System. This is an exciting opportunity for you to work as part of a supportive, collaborative team in a state-of-the-art facility.

Responsibilities:
  • Ensure compliance with regulatory requirements, including Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745, and FDA Quality System Regulations 21 CFR 820 & 803.
  • Maintain and continuously improve the quality management systems.
  • Act as Coordinator for CAPA, Complaints & Temporary Authorization (Deviations) processes to support owners in meeting required timelines.
  • Review and approval of Non-conformance, CAPA, and Complaint investigation reports.
  • Act as Coordinator for the Audit Management Process, managing the annual audit schedule and coordinating internal and external audits as required.
Required Skills and Qualifications:
  • Educated to a minimum Diploma Level in an Engineering, Science, or Quality Assurance discipline.
  • Training/Qualification in Quality Systems, Complaints, and CAPA is highly desirable.
  • A minimum of five years' relevant experience in the medical device industry.
  • Familiarity with ISO13485, ISO14971, Medical Device Regulation 2017/745, and FDA QSRs is required.
  • Experience in management of Quality Systems activities, particularly Complaints and CAPA, is desirable.
Benefits:

Bonus, pension, healthcare, hybrid working