Job Title: Senior Supervisor, Design Quality Assurance
Location:Galway (Hybrid)
Category: Quality / Medical Devices / Engineering
Join a high-performing team driving innovation in the medical device industry. We are currently seeking a Senior Supervisor, Design Quality Assurance on a permanent basis to lead engineering talent and ensure the highest standards in product quality, compliance, and patient safety.
This is an opportunity to take ownership of a diverse and impactful product portfolio, contribute to meaningful projects, and help shape the future of medical technology.
Job Purpose
This role sits within the Design Quality Assurance function, supporting a wide range of interventional cardiology devices, including:
* Drug-eluting therapies (e.g., drug-coated stents and balloons)
* Balloon dilatation catheters
* Cutting balloons
* Micro-catheters
You’ll lead small to medium-sized design change projects and oversee a team of at least 3 engineers, providing coaching, mentoring, and technical direction. Responsibilities also span post-market surveillance, compliance activities, and driving continuous improvement — all while ensuring regulatory alignment and high-quality execution.
Key Responsibilities
* Lead and manage design change projects from scoping to implementation.
* Ensure all design changes comply with Design Control and Design Assurance requirements for medical devices.
* Serve as a quality leader in addressing PIRs, CAPAs, NCEPs, and responding to regulatory changes.
* Collaborate cross-functionally with teams in R&D, Regulatory Affairs, Medical Safety, and Operations.
* Analyze test data and apply strong problem-solving methodologies to support decision-making.
* Lead updates to Risk Management documentation, such as Hazard Analyses, Task and Use Error Analyses, and Design FMEAs.
* Ensure compliance with relevant regulatory requirements (EU/FDA/global), SOPs, and internal procedures.
* Support internal and external audits as needed.
* Contribute to post-market surveillance, including Field Signal Evaluations, performance assessments, PSURs, and regulatory Q&A.
* Coach and develop engineers within your reporting structure, assigning and managing project work within the sustaining engineering environment.
Technical & Educational Requirements
* NFQ Level 8 qualification in a STEM discipline.
* Minimum 6 years of industry experience, preferably in Design Assurance.
* Demonstrated experience in:
o Design control & design change
o Risk management & regulatory compliance
o Quality systems and document control
* Strong technical capabilities, leadership skills, and analytical thinking.
* Excellent verbal and written communication.
* Able to work independently and collaboratively across functions.
* Motivated to drive quality, compliance, and continuous improvement.
Leadership & Soft Skills
* Proven ability to coach and lead engineering teams.
* Strong communication and collaboration skills across functions.
* Results-oriented with a proactive approach to problem-solving.
* Committed to delivering high-quality outcomes and advancing team performance.
Why Apply
* Join a team focused on product quality, compliance, and patient safety.
* Contribute to mission-critical technologies in a highly regulated and innovative industry.
* Work on impactful projects with opportunities to mentor, lead, and grow.
* Be part of a collaborative, high-performing environment that values your expertise and development.
Ready to Lead the Future of Quality in Medical Devices?
If you're a quality-driven leader passionate about technical excellence and coaching others while solving complex challenges — we’d love to hear from you.
Apply now to learn more.
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