Quality System Specialist

Location: Central London | Hybrid - once a week on site Type: 6-Month Fixed Term Contract Cure Talent is delighted to be working with an innovative MedTech company revolutionising ear and hearing healthcare With their ongoing growth and exciting projects, we have a fantastic opportunity for a QMS Specialist to join them on a 6-month fixed-term contract. We are looking for an experienced Quality Professional to support the development and implementation of an efficient and compliant ISO 13485 QMS. You will play a pivotal role in preparation for external audits, assisting various departments, and driving continuous improvement initiatives across the organisation. The ideal candidate will have a strong, proven background in Medical Devices with experience of implementing or developing an ISO 13485 QMS (eQMS experience is a bonus), SOP writing, Document Control, Change Control, CAPA, Non-Conformance Management & Complaint Management. Key Responsibilities: Support the QARA Manager in managing and developing the QMS to ensure compliance with ISO 13485, EU MDR, and FDA requirements. Assist departments in identifying, investigating, and resolving non-conformances for software and hardware medical device components. Act as CAPA lead, managing all phases, including root cause analysis, risk evaluation, corrective/preventive actions and closure. Monitor CAPA status to ensure actions are completed in a timely and effective manner. Provide guidance to address audit findings, validate software used in the QMS, and maintain SOPs and quality records. Perform daily QMS management tasks and support warehouse and customer support teams, including occasional travel to Site in Exeter. The ideal candidate will have the following skills and experience: Proven experience in a Quality role within the Medical Device industry. Strong working knowledge of ISO 13485, EU MDR, and FDA regulations. Experience in Document Control, Change Control, CAPA, NCR, and Complaint Management. Excellent attention to detail with strong communication and organisational skills. A collaborative team player who can work independently when required. If you're looking for an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today

Location: Soho, GB

Posted Date: 2/5/2025