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Quality Assurance Manager
2 months ago
Cure Talent is proud to partner with a leading global company in medical diagnostics and in-vitro diagnostic products. Their reputation for delivering accurate, user-friendly solutions that empower individuals to take control of their health is unparalleled.
This is an exciting opportunity for an experienced Quality Systems Manager to join their highly motivated team. The successful candidate will be responsible for leading and managing the quality systems team, ensuring the effectiveness of the Quality Management System (QMS), and maintaining compliance across the design, development, manufacture, and distribution of in-vitro diagnostic medical devices.
Key responsibilities include:
- Leading and managing the quality systems team to ensure the effectiveness of the QMS.
- Maintaining compliance with regulatory requirements, including ISO 13485, Council Directive 98/79/EC, In-Vitro Diagnostic Medical Device Regulation 2017/746, UK CE Mark, and US FDA 21 CFR Part 820.
- Developing and implementing quality management systems to ensure compliance with regulatory requirements.
- Conducting audits and assessments to ensure compliance with regulatory requirements.
- Providing training and guidance to employees on quality management systems and regulatory requirements.
We are looking for a Quality Systems Manager with the following skills and experience:
- Strong experience managing quality and compliance in a medical device environment.
- Knowledge of compliance management throughout the full design control lifecycle under ISO 13485 and US FDA 21 CFR Part 820.
- Lead Auditor qualification or relevant experience (preferred but not essential).
- A track record of improving established Quality Management Systems.
- Proven leadership and people management skills, with the ability to inspire and influence key stakeholders at all levels.
If you want to be part of an organisation that's passionate about people and innovation in healthcare, this is a fantastic opportunity to lead a talented team and make a positive impact.
