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Senior Quality Engineer

Ref: 9217499

  • Negotiable
  • 17 Jun 2019
  • Limerick
  • Perm



The Role

The Senior Quality Engineer role will provide Quality Assurance guidance and ensure compliance in the support of combination device development life cycles from design control through to regulatory submissions and sustainability. Our client, is a world-class pharmaceutical and biotechnology company Fantastic package including bonus, pension, healthcare (plus a lot more)

Core Responsibilities:

  • Review and support development of Design Control records for compliance to internal procedures and regulations (ISO13485, 21CFR Part 820)
  • Review technical reports as well as documents
  • Participate in device risk management activities in accordance with ISO14971
  • Evaluation and contribution of regulatory information to applicable documents.
  • Support external and internal manufacturing to evaluate and approve change notifications
  • Education and Experience:

  • Relevant degree in Engineering with 7+ years of related experience.
  • 4+ year experience in the combination device or medical device industry.
  • Proven experience in post design transfer
  • Experience with post market complaint handling
  • If you’re interested in this or other medical device jobs, please contact Emma O’Carroll on 021 422 1000 or email mailto:e.ocarroll@brightwater.ie