Senior Quality Assurance Specialist

2 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €80,000 - €100,000

Job Title:

Senior Quality Assurance Specialist

We are seeking an experienced Senior Quality Assurance Specialist to play a key role in the implementation and maintenance of our quality management systems.

Key Responsibilities:

  • Ensure that all quality systems are compliant with relevant regulations, including Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, ISO 14971 and Japanese Ministerial Ordinance #169.
  • Maintain and continuously improve our quality management systems.
  • Coordinate CAPA, Complaints & Temporary Authorization (Deviations) processes to support owners in meeting required timelines.
  • Review and approve Non-conformance, CAPA and Complaint investigation reports.
  • Coordinate Audit Management Process, manage annual audit schedule and coordinate internal and external audits as required.
  • Track audit actions from initiation to closure.
  • Manage quality systems data collection and analysis to facilitate timely generation of Monthly Reports, Management Review data etc.
  • Prepare and present data to management on quality system performance.
  • Generate quality systems data as required for Post Market Surveillance purposes.
  • Act as primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements.
  • Provide quality review on range of documentation including procedures, specifications, investigations and other quality management system documentation.

Requirements:

  • Educated at minimum to 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 relevent experience in medical device industry.
  • Familiarity of ISO13485, ISO14971, Medical Device Regulation 2017/745 and FDA QSRs is required.
  • Experience in management of Quality Systems activities, in particular Complaints and CAPA is desirable.

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