Quality Engineer I – Medical Devices

Pale Blue Dot Recruitment; Cork; On-site; EUR 40,000 - 55,000; Full time

Job summary

A dynamic medical device start-up is seeking a Quality Engineer I to apply engineering knowledge in improving their Quality Management System. Located in Galway, the role involves ensuring compliance with ISO standards and supporting product development. A Bachelor’s degree and 2 years’ experience in the medical device field are required. The ideal candidate will have strong problem-solving skills and familiarity with regulatory environments.

Qualifications

• 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.
• Strong initiative and problem-solving skills.

Responsibilities

• Apply quality engineering expertise across the Quality Management System (QMS).
• Support certification to ISO 13485 and 21 CFR Part 820.
• Assist with design assurance activities.
• Maintain document control and perform administrative tasks.
• Contribute to CAPA and NC investigation and resolution.

Skills

Quality management expertise

ISO 13485 knowledge

Problem-solving skills

Initiative

Understanding of risk management

Education

Bachelor’s degree in engineering or science

Tools

MS Office

Electronic QMS tools

Job description

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

Location: Galway (On-site)
Industry: Medical Device / Start-up

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.

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.