Lead Quality Systems Specialist

1 week ago

Galway, Galway, Ireland beBeeQuality Full time €80,000 - €100,000
Senior Quality Systems Engineer

We are seeking an experienced Senior Quality Systems Engineer to join our team. Located in Galway, this is an exciting opportunity to work on the implementation and maintenance of quality management systems for a growing medical device company.

  • This role will involve ensuring compliance with relevant regulations and standards including Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, ISO 14971, and Japanese Ministerial Ordinance #169.

You will be responsible for maintaining and continuously improving our quality management systems, coordinating CAPA, Complaints & Temporary Authorization (Deviations) processes, and reviewing and approving Non-conformance, CAPA, and Complaint investigation reports.

To succeed in this role, you will need:

  • A minimum Diploma Level education in Engineering, Science, or Quality Assurance.
  • Training in Quality Systems, Complaints, and CAPA is highly desirable.
  • At least five years' experience in the medical device industry.
  • Familiarity with ISO13485, ISO14971, Medical Device Regulation 2017/745, and FDA QSRs is required.
  • Experience in managing Quality Systems activities, particularly Complaints and CAPA, is desirable.

We offer a supportive team environment and opportunities for professional growth and development.

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