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Senior quality engineer

Galway
STEM Recruitment Partners
Quality engineer
Posted: 19 November
Offer description

Job Title:Senior Quality Engineer (Contract)Location:Galway – Hybrid (2–3 days onsite, potential to ramp up)4 months with a potential for extension.Rate:Up to €60/hour DOEStart Date:ImmediateAbout the RoleSTEM Recruitment Partners is teaming up with a leading Galway-based engineering consultancy to support one of their medical device clients on a key project over the next few months. This is an immediate contract opportunity for an experienced Senior Quality Engineer to play a key role in ensuring validation compliance, documentation integrity, and audit readiness within a fast-paced project environment.This role would suit someone who has just finished their previous contract or is looking to return to work.Key ResponsibilitiesReview, edit, and where required draft validation documents (URS, DQ, IQ/OQ/PQ protocols, trace matrices) aligned with project deliverables.Ensure documentation meets all QMS and regulatory standards, including FDA, ISO 13485, and EU MDR.Collaborate closely with validation and engineering teams to triage and progress documentation packages efficiently.Participate in document review workflows to minimize QA rework and improve turnaround times.Support deviation documentation, risk assessments (e.g., FMEA), and CAPA activities as necessary.Drive audit readiness by maintaining strong document control and traceability across all validation efforts.Represent QA in daily or weekly project stand-ups, tracking progress, flagging issues, and supporting resolution through teamwork and clear communication.Ideal Profile8+ years of experience in medical device validation and quality systems.Proven ability to manage multiple documentation deliverables simultaneously.Excellent attention to detail and cross-functional communication skills.

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