This regenerative medicine company focused on Orthobiologics are looking for a Quality Assurance Specialist for a 9-12 month FTC. Both part time and full time applications will be considered.This medical device company are seeking a talented and motivated individual to support the Quality Assurance & Regulatory Affairs (QARA) function.Reporting to the QARA & Clinical Director, this role is crucial in maintaining and improving the Quality Management System (QMS) in line with ISO 13485:2016 and 21 CFR Part 820 requirements while fostering a compliance-focused culture.The Quality Assurance Specialist will support the QARA & Clinical Director in ensuring compliance and continuous improvement of the Quality Management System (QMS). They will act as the lead document controller, ensuring that all documentation is properly created, reviewed, approved, and updated in accordance with company Standard Operating Procedures (SOPs).Key Responsibilities: Maintain and update QMS databases, including Document Register, Non-Conformances, CAPAs, Change Controls, Training, and Standards. Chair Change Control Committee meetings and oversee the progress of change controls. Oversee supplier review, approval, and monitoring to ensure material and service quality. Ensure effective handling of non-conformances, CAPAs, feedback, and complaints. Support third-party audits and regulatory inspections. Implement new Policies Conduct internal audits in line with the internal audit programme. Required Skills & Qualifications: Degree in a life sciences or related discipline, or equivalent experience. Experience in a medical sector working within ISO 13485:2016 is essential (experience with 21 CFR Part 820 is an advantage). Prior experience conducting internal audits within a QMS environment (preferred). A proactive, can-do attitude with the ability to meet ambitious goals. High levels of integrity, able to work independently with minimal supervision. Strong communication skills, comfortable working within a small, flexible, and fast-paced team. This is a great opportunity to work within an innovative and growing company as part of a supportive and collaborative team, with flexible hours and the potential for remote working.