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 ...