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We are currently seeking a dynamic and experienced Quality Manager to join our client's team in Worksop. In this role, the Quality Manager will be responsible for the maintenance of the Quality Management System, ensuring compliance with ISO standards and applicable regulations.
Responsibilities:
- Lead the effective maintenance, and continuous improvement of the Quality Management System, in line with ISO standards and customer requirements.
- Collaborate closely with top-level management to develop and implement the Quality Plan, Quality Policy, and Quality Objectives.
- Manage and lead the Quality Assurance team, fostering a culture of excellence and promoting best practises.
- Provide training and mentoring to team members, ensuring they are equipped with the necessary skills for quality assurance and regulatory compliance.
- Develop, implement, and maintain quality assurance programmes that align with regulatory requirements and industry standards.
- Oversee New Product Development initiatives, providing high-quality input into design control, validation, and risk management processes.
Qualifications, Skills, and Experience:
- Minimum of 6 years of experience in Quality Assurance within the medical device industry, with at least 2 years of managerial experience.
- Strong understanding of regulatory standards and guidelines relevant to medical devices, such as ISO 13485 and FDA 21 CFR Part 820.
- Experience in New Product Development and related quality processes.
- Experience maintaining CE marked medical devices under the Medical Device Directive (MDD) and knowledge of the new European Medical Devices Regulation (MDR).
