Are you an organised, proactive, and detail-driven professional with a passion for quality and continuous improvement? Do you have experience or a genuine interest in medical devices? Do you thrive in a fast-paced environment where cross-functional collaboration and precision are key? If so, this could be the role for you.
I am looking for a Quality Assurance Project Coordinator to play a central role in managing and coordinating quality change control projects across our organisation. This is a fantastic opportunity to influence and maintain the highest standards within a dynamic and growing business.
Everything you need to know about the role –
* As the Quality Assurance Project Coordinator, you will oversee the document control and change control processes to ensure ongoing compliance with ISO 13485 and ISO 9001. Working closely with key stakeholders across head office and acquired companies, you will lead project meetings, ensure actions are completed within agreed timelines, and gather evidence to successfully close out projects.
* Coordinate and lead quality, document, and product-related change control projects.
* Bring together cross-functional project teams across multiple sites to drive projects to completion.
* Develop and maintain project plans, ensuring all stakeholders remain aligned and engaged.
* Manage the full change control process, from initiating actions to chairing meetings and ensuring timely closure.
* Generate trend analysis and reports.
Experience and qualities that make you a strong fit
Essential:
* Experience working within a Quality Management System, ideally in a medical device environment.
* Strong project management experience.
* Demonstrated ability to set and monitor KPIs.
Desirable:
* Experience completing change controls in accordance with ISO 13485 and ISO 9001.
* Excellent interpersonal skills and the ability to collaborate across all levels and functions.
* Strong organisational skills with exceptional attention to detail.
* Clear and confident written and verbal communication.
What’s on offer? –
* Hybrid working – 3 day per week in the office (just outside of York), the rest WFH.
* Small, friendly, down-to-earth team – no big egos, and everyone is very collaborative in their approach
* Competitive remuneration and benefits package
* Excellent training & development as well as good career progression