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:
• Design control & design change
• Risk management & regulatory compliance
• 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.