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.
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