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Quality Engineer I – Medical Devices

  • On-site, Hybrid
    • Galway, Ireland
  • Quality Assurance

A dynamic and fast-paced medical device start-up based in Galway, is seeking a Quality Engineer I to join their growing team.

Job description

Location: Galway (On-site)
Industry: Medical Device / Start-up
Our client, a dynamic and fast-paced medical device start-up based in Galway, is seeking a Quality Engineer I to join their growing team. 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.

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, start-up environment and contributing directly to impactful product development.

Responsibilities include but are not limited to the following:

  • 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.

  • Collaborate cross-functionally to uphold quality objectives and continuous improvement.

  • Perform additional quality-related duties to support business goals and KPIs.

Job 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.

  • Strong initiative, problem-solving, and follow-through in executing responsibilities.

  • Understanding of risk management methodologies (ISO 14971).

  • Experience with sterilization (EtO/Gamma), biocompatibility, and transportation testing is a plus.

  • Prior involvement in audits or inspections is an advantage.

  • Proficiency in MS Office and familiarity with electronic QMS tools.

Immediate interviews available for suitable candidates.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other future vacancies.

                                    -Pale Blue Dot® Recruitment , The Resource for the MedTech Workforce-

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