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Quality Engineer (Medical Devices)

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Quality Engineer (Medical Devices)

Our client is a well-established manufacturer of high quality microbiology consumables.  Due to continued expansion a new position has arisen for an experienced Quality Engineer.

The successful candidate will lead the Quality and Regulatory Compliance function and will have day to day responsibility for the management and continuous effectiveness and improvement of the ISO 13485 Quality management system and compliance with the Medical Device and In-Vitro Diagnostic Device legislation

Reporting to : Technical Director

Duties will include:
Maintenance and improvement of the ISO 13485 Quality System
Understand and implement current and emerging regulations (e.g. MDD 93/42/EEC, IVD 98/79/EC, proposed MDR)
Host notified body audits
Identify and drive improvement to the QMS
Engage all internal functions in the operation and improvement of the QMS
Compiling and updating regulatory files
Managing internal audits, identifying gaps, updating system and or training to address identified needs
Liaising with external regulators (e.g. MHRA, notified Bodies)
Assist with preparation of Technical Files
Manage Quality Assurance function
Promote Quality, Quality Management system awareness at all levels of the business

Experience :
Have worked at a similar level in a ISO 13485 Medical Device manufacturing environment
Developed and implemented ISO 13485 Procedures
Working knowledge of relevant standards
Process validation
Requirements of MDD technical files
Strong analytical and problem solving skills
Identify root cause and implementation of solutions (FMEA)
Ability to drive multiple projects simultaneously
Requirements of IVD Directive
Knowledge of product life cycle risk assessment techniques
Knowledge of sterilisation standards
Knowledge and practical experience with analytical / statistical techniques
Experience of ISO 13485:2016
Experience of ISO 9001:2008