Quality Manager

2 weeks ago

City Of London, United Kingdom Artisan People Full time

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. 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. How You'll Dazzle Us 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. What's Next Ready to take on this exciting challenge? Apply via the form below. #J-18808-Ljbffr

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