Design Quality Assurance Supervisor

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 pkiely@sigmar.ie
• Or if the job isn’t quite right but you are looking for something similar, please get in touch.