Medical Device Quality Assurance Specialist

4 days ago

Cork, Cork, Ireland beBeeQuality Full time €50,000 - €65,000

We are seeking a talented Quality Engineer I to join our team.

Key Responsibilities:
  • Apply quality engineering expertise across the Quality Management System (QMS) ensuring compliance with regulatory standards.
  • Support certification and maintenance of compliance to ISO 13485 and 21 CFR Part 820.
  • Collaborate in design assurance activities, including design controls, verification, and validation.
  • Assist in development and validation of test methods and computer system assurance programs.
  • Participate in risk management and usability engineering activities.
  • Maintain document control through QT9 eQMS and perform related administrative tasks.
  • Contribute to the CAPA and non-conformance (NC) investigation and resolution process.
  • Assist in internal and external audits and implement corrective actions as needed.
  • Support updates and gap assessments for applicable regulatory standards and guidance.
  • Participate in supplier quality management, vendor evaluation, and AVL maintenance.
  • Collaborate cross-functionally to uphold quality objectives and drive continuous improvement.

Bachelor's degree in engineering, science, or a related field is required. A minimum of two years' experience in a medical device or supplier environment is also necessary.

Familiarity with ISO 13485, FDA QSR (21 CFR Part 820), and GMP requirements is essential. Experience in both FDA and European regulatory environments is preferred.

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