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.