About your new job:
We have an excellent opportunity for a
Design Quality Assurance Supervisor,
to join a leading medical device manufacturer.
This role involves leading projects within the balloon catheter product family, supervising a team of at least three engineers, and ensuring all design changes meet regulatory and procedural requirements.
Key responsibilities include post-market surveillance, quality, compliance, material continuity, and Value Improvement Projects.
Key Responsibilities as a Design Quality Assurance Supervisor:
Strong understanding of medical device Design Control requirements and procedures.
Expertise in Design Assurance to ensure projects comply with internal standards and regulatory requirements.
Lead the resolution of PIRs, CAPAs, NCEPs, and regulatory changes with design quality oversight.
Collaborate with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations to provide technical and quality guidance.
Interpret test data and make decisions using excellent analytical and problem-solving skills.
Manage design change projects, from scoping and assessment to implementation, guiding team members as needed.
Maintain and update Risk Management File documentation, including Hazard Analysis, Task and Use Error Analysis, and Design FMEA.
Ensure ongoing regulatory compliance with SOPs/WIs and EU/FDA/global guidelines.
Apply structured problem-solving methods to identify, prioritize, and resolve quality issues.
Support internal and external regulatory audits as required.
Oversee post-market surveillance activities, including field product assessments, NCEPs, PSURs, and regulatory queries.
Provide coaching and mentoring to team members, including oversight of small to medium projects.
What skill/experience you need as a Design Quality Assurance Supervisor:
NFQ Level 8 qualification in a STEM field.
At least 6 years' industry experience, ideally including Design Assurance.
Skilled in design control, risk management, design changes, and regulatory compliance.
Strong leadership, problem-solving, technical, communication, and teamwork abilities.
Able to work autonomously and collaboratively.
Driven to advance their career, promote best practices, and continuously improve product and process quality.
Committed to mentoring and developing team members.
What's on offer?
€70,000 - €80,000 salary
Great benefits package
What's next?
Apply now by clicking "Apply Now" or contact me at
Or if the job isn't quite right but you are looking for something similar, please get in touch.
#J-18808-Ljbffr