Quality Engineer

3 weeks ago

Galway, Galway, Ireland Pale Blue Dot®Recruitment Limited Full time

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.

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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