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 DOE
Start Date:
Immediate
About the Role
STEM 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 Responsibilities
* Review, 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 Profile
* 8+ 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.