12 month fixed term contract
You will be joining a leading science-backed health and beauty brand as Quality Manager.
The Role
This is a brilliant opportunity for an experienced Quality professional to step into a pivotal, hands-on role reporting directly to the Operations Director. You’ll be instrumental in developing, implementing, and maintaining a robust Quality Management System (QMS) for cutting-edge medical and Annex XVI devices.
Key responsibilities:
* Maintain and continually improve the QMS in accordance with ISO 13485:2016, FDA QSR, MDSAP, and EU MDR.
* Ensure product compliance with EU MDR General Safety and Performance Requirements (GSPRs) and mandatory Common Specifications (CS).
* Manage the company’s proactive Post-Market Surveillance (PMS) system in line with EU MDR, including developing PMS plans and compiling PSURs.
* Plan, conduct, and manage internal audits across all departments and levels.
* Implement and manage risk management activities in accordance with ISO 14971.
* Establish and maintain the supplier qualification, evaluation, and monitoring programme, including conducting supplier audits.
* Train employees on quality standards, regulatory requirements, and company procedures.
Sound like you?
We’re looking for someone who brings 5-7 years of progressive experience in a Quality Assurance role within the medical device sector. You will have demonstrable experience managing a QMS compliant with ISO 13485:2016 and FDA 21 CFR Part 820. Your technical knowledge must be expert level, with an in-depth understanding of the EU Medical Device Regulation (MDR 2017/745), including Technical Documentation, PMS, and Clinical Evaluation.
Crucially, you’ll be a proactive leader, proficient with QMS software and comfortable adapting to and implementing new digital tools to streamline processes. Experience with Annex XVI devices or MDSAP audits would be a real advantage.