Lead Quality Assurance Professional
We are seeking a highly skilled Lead Quality Assurance Professional to drive our Quality Management System and key manufacturing activities. This role requires technical knowledge, practical application, and cross-functional leadership as we transition our innovative product through design, production, and regulatory milestones.
1. QMS Leadership: Drive the implementation and continuous improvement of our QMS.
2. Design Assurance: Collaborate with R&D to develop and review essential technical documentation, including test specifications, part specifications, and design specifications.
3. Manufacturing Support: Provide QA support for regulated manufacturing, including equipment qualification, process validation, and change control.
4. Compliance & Audit: Coordinate and manage critical quality processes, including the internal audit programme, Material Review Board, NC/CAPA reviews, and the complaint process.
5. Regulatory & Supply Chain: Interpret relevant international standards (ISO 13485, FDA) to ensure compliance. Support the supply chain team with supplier development and manufacturing requirements.
6. Project Support: Provide quality expertise for regulatory submissions and clinical investigations.
Key Skills & Qualifications:
* Education: Bachelor's Degree in Engineering, Science, or a related field.
* Experience: Minimum of 5+ years' recent experience in a Medical Device Quality or Design Assurance role.
* Regulatory Expertise: Strong, recent experience interpreting and applying major regulations, including FDA regulations and ISO 13485.
* Skills: Exceptional attention to detail, strong analytical and problem-solving abilities, and an aptitude for identifying and implementing process improvements.
* Team Player: Excellent communication and influencing skills with a proven ability to collaborate effectively across R&D, Manufacturing, and Supply Chain teams.
About this Role:
This is an exciting opportunity to lead our quality assurance efforts and contribute to the success of our company. As a Lead Quality Assurance Professional, you will be responsible for driving our QMS and ensuring compliance with relevant regulations. If you have a passion for quality assurance and a strong background in medical devices, we encourage you to apply.