Senior Quality Management Specialist

2 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €60,000 - €80,000
Job Overview

We are seeking a highly skilled professional to fill the role of Senior Quality Systems Engineer in our organization.

Key Responsibilities:
  • Ensure compliance with 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.
  • Maintain and continuously improve quality management systems.
  • Coordinate CAPA, Complaints & Temporary Authorization (Deviations) processes to support owners in meeting required timelines.
  • Review and approval of Non-conformance, CAPA and Complaint investigation reports.
Requirements:
  • Degree or higher in an Engineering, Science or Quality Assurance discipline.
  • Desirable qualifications in Quality Systems, Complaints and CAPA.
  • Minimum 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 managing Quality Systems activities, particularly Complaints and CAPA is desirable.

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