Senior Quality Assurance Specialist

22 hours ago

Cork, Cork, Ireland beBeeQualityEngineer Full time €45,000 - €60,000

We are seeking a Quality Engineer I to join our medical device start-up based in Galway.

Job Description

This role offers a unique opportunity for a motivated and hands-on quality professional to apply their engineering knowledge across multiple areas of a developing Quality Management System. The ideal candidate will enjoy working in a cross-functional, dynamic environment and contributing directly to impactful product development.

The company is focused on developing innovative, patient-centric technologies to improve quality of life and is advancing rapidly through the product development lifecycle toward global market launch.

Responsibilities
  • Apply quality engineering expertise across the Quality Management System (QMS).
  • Support certification and maintenance of compliance to ISO 13485 and 21 CFR Part 820.
  • Assist with design assurance activities, including design controls, verification, and validation.
  • Support 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.
Requirements
  • Bachelor's degree in engineering, science, or related field (or equivalent).
  • Minimum of 2 years' experience in a medical device or supplier environment.
  • Familiarity with ISO 13485, FDA QSR (21 CFR Part 820), and GMP requirements.
  • Experience in both FDA and European regulatory environments is preferred.

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