Quality Assurance Team Leader

Quality Assurance Team Leader

We are seeking a Quality Assurance Team Leader to join a medical device company that is growing its team. Your role will be to support and maintain the QMS, ensuring compliance with ISO13485 and other relevant regulations. The role involves working across departments, advising on quality management processes, supporting suppliers and customers, and promoting continuous improvements. Experience in the medical device or IVD industry and software validation is preferred.

Responsibilities:

* Support implementation and maintenance of QMS processes

* Administer eQMS system (QT9)

* Conduct audits and ensure compliance

* Train employees on QMS procedures

* Monitor performance and suggest improvements

* Provide backup for QA team admin tasks

Qualifications:

BSc in a relevant scientific discipline or equivalent experience

5+ years of ISO13485 QMS experience

2+ years in IVD or medical device industry

Knowledge of ISO13485, 21 CFR Part 820, and relevant regulations

Strong communication and collaboration skills

Experience with QMS systems and document control

The role requires a self-motivated individual with a strong attention to detail and ability to work across teams.

To be considered for this opportunity you will need to have the right to work in the UK.