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Quality Assurance Specialist
2 weeks ago
About this role:
We have an excellent opportunity for a Quality Assurance Specialist to join our team. This role involves leading projects within the product family, supervising a team of 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.
- 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.
Required Skills and Qualifications:
- 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.
Benefits:
- Possible salary range: €70,000 - €80,000 per year.
- GREAT benefits package.
What's Next:
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