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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