Job description
An innovative and growing medical technology company are recruiting a pro-active and experienced Quality Manager to utilise their experience across pharmaceuticals and medical devices to take take ownership of the QMS, ensure compliance with ISO standards, GLP/GMP principles and regulatory requirements while driving audit readiness and operational quality across a growing R&D business.
Quality Manager Key Responsibilities:
- Improve, maintain and optimize the company QMS
- Ensure compliance with ISO 13485, ISO 10993, GxP principles and ICH guidelines
- Create, review, and approve SOPs, work instructions, and validation protocols
- Manage document control and ensure Good Documentation Practices (GDP)
- Deliver SOP and quality training for all employees and across all departments; maintain training records
- Coordinate internal, supplier, and external audits.
- Support regulatory inspections and certification processes.
- Track and ensure timely closure of audit findings and CAPAs.
- Oversee laboratory and cleanroom quality compliance.
- Participate in deviations, change controls, CAPA, complaints, and recalls.
- Conduct risk assessments and root cause analyses.
- Support supplier qualification and monitoring.
Expert knowledge and experience of QA in both pharma and medical devices is expected. A high level of commitment and drive is key to success in this standalone role in a start up environment.
This is a hybrid, predominantly remote role, offering a highly competitive salary plus excellent benefits including a company share plan, private health cover and generous pension contribution.
Extra information
- Status
- Open
- Education Level
- Secondary School
- Location
- Oxford
- Type of Contract
- Full-time jobs
- Published at
- 26-03-2026
- Full UK/EU driving license preferred
- No
- Car Preferred
- No
- Must be eligible to work in the EU
- No
- Cover Letter Required
- No
- Languages
- English
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