Job Description
Senior Quality Associate
Bicester - onsite 4 days per week.
A growing, independently owned medical device organisation with a strong reputation for quality and innovation, supplying products globally.
Everything you need to know about the role:
This is an excellent opportunity for a Quality professional to join a collaborative and evolving medical device business. You’ll play a key role in maintaining and improving the Quality Management System (QMS), ensuring compliance with regulatory standards and supporting the wider quality function across the organisation.
Working closely with the Quality leadership team, you’ll gain exposure to a broad range of quality activities including audits, supplier management, and product release processes.
You will:
* Support the maintenance and continuous improvement of the Quality Management System (QMS)
* Coordinate change control processes across manufacturing, design, and documentation
* Manage document control activities, ensuring accuracy and compliance
* Lead coordination of non-conformities and CAPA processes, including effectiveness checks
* Support supplier quality activities and documentation
* Assist with product release for sale and inspection activities
* Participate in internal and external audits and support audit preparation
* Ensure timely completion and review of quality documentation
Experience and qualities that make you a strong fit:
* Experience working within a QMS, ideally in the medical device sector
* Familiarity with ISO 9001 (or similar standards)
* Experience with change control, non-conformities, and CAPA processes
* Proactive, “can-do” attitude with the ability to manage multiple priorities
Preferred:
* Experience supporting audits (internal and external)
* Exposure to supplier quality management
* Experience in regulated environments (e.g. medical devices or similar industries)
What’s on offer:
* Opportunity to join a growing and supportive organisation
* Broad exposure across quality and compliance activities
* Career development within a regulated industry
* Collaborative and team-focused environment
Could this be the role for you?
If you’re a detail-oriented Quality professional looking to develop your career within a medical device environment, this could be a great next step. Apply now or get in touch to find out more.