Quality Manager – GLP – ISO 13485 – Hybrid
Bond Williams
Professional Recruitment
An innovative and growing medical technology company are recruiting a pro-active and experienced Quality Manager to implement a QMS and ensure compliance with ISO standards, GLP/GMP principles and regulatory requirements while overseeing audit readiness and operational quality across a growing start up business.
Quality Manager Key Responsibilities:
- Implement, maintain and optimize the company QMS (BPA or other).
- Ensure compliance with ISO 13485, ISO 900, GMP/GLP/GCP principles and ICH guidelines
- Draft, 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.
Extensive experience of QA in medical device, biotech and/or pharma is expected and the commitment and gravitas take on a management role in a small start up environment is key to success in the Quality Manager role.
A highly competitive salary plus benefits including a good pension contribution, company shares and flexible working are all on offer to the successful candidate.
Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency
