Quality Assurance Manager - Medical Devices
Location: REMOTE - UK
My client is a CRO that provides services to world renown pharmaceuticals, biotechs, medical device companies and more. They are in an exciting time building up several teams in Europe, and working with some of the largest pharmaceuticals and biotechs in the world. They now have an immediate requirement for a QA Manager to be part of their journey on a permanent and remote basis.
• The Medical Device Quality Assurance Specialist supports, and reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
• Reports to QA Manager / Management to create new Quality System procedures/instructions
• Monitor and maintenance of existing processes
• Lead & support all internal and external audits
• Support in creating and maintaining internal audit schedules and records including tracking CAPA activities as required
• Supports preparation and execution of Notified Body audits and prepare reports.
• Support preparation of technical files for compliance to UK regulations.
• Assist in investigating quality issues and interact with products suppliers regarding these
• Review and investigate customer complaints, determine product failure root causes and evaluate risk of failures
• Ensure that the quality system is understood and applied throughout the organisation on all levels by personnel concerned
• Authorising product release to stock and completion of relevant records upon receipt
• Maintenance of technical files, and test reports of product conformity according to MDR Regulation (EU) 2017/745 and MDD 93/42/EEC and amendments 2007 (be aware of the latest regulation)
Key Skills and Qualifications
• Knowledge of quality systems (ISO 13485)/ ISO 9001, associated documentation
• Knowledge of medical device regulations (MDR Regulation (EU) 2017/745 and UK MDR 2002, MDD 93/42/EEC), and SaMD regulations.
• Country specific QMS such as 21 CFR Part 820 for US would be added advantage
• Bachelor’s/Master’s degree in a related field with at least 10 years of relevant QA experience within the pharmaceutical, medical device, and/or biotechnology industry.
• At least 10 years’ experience working in a regulated environment
• Be aware of the latest medical device regulations
• Very proficient in attention to detail and ability to work in collaborative & independent work situations.
• Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment
• Knowledge of Microsoft Office including Excel, with an ability to learn other computer based systems.
• Ability to remain calm and receptive in fast paced situations
Mid - Senior