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!