Senior Supervisor Design Quality Assurance

Hero Recruitment

  • Galway
  • Permanent
  • Full-time
  • 24 days ago
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 PurposeThis 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.

Hero Recruitment