Design Quality Assurance Supervisor

Sigmar Recruitment

  • Co Galway
  • €70,000 per year
  • Permanent
  • Full-time
  • 17 days ago
  • Apply easily
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.

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