*** Exclusive vacancy to Indo Professionals ***
Quality Engineer – Hampshire
An excellent opportunity to join a growing medical device manufacturer with huge investment. Our client offers a stable platform for employee empowerment and excellent progression opportunities.
Our client is a market leading medical device developer based in Hampshire. Due to continued and consistent growth they have created a new position for a Quality Engineer to support the leadership team in line with their quality management system (QMS).
Our client is an established medical device company with award winning technologies sold globally.
Our client is willing to pay market rates for experienced Quality Engineers, please call today for a salary consultation.
Hampshire – office based with occasional international travel. Ideal for any Quality Engineer residing in or near the areas of Southampton, Winchester, Basingstoke, Hook, Yately, Guildford, Reading, Newbury, Oxford, Portsmouth, Farnham, Aldershot, Farnborough, Fleet, Bracknell, Woking, Camberley, Andover, Eastleigh, M3 corridor or someone willing to relocate
- Ideally 5 or more years’ experience in a quality engineering / assurance capacity, ideally within electronics / active medical devices
- HND or relevant degree in an engineering or related discipline or equivalent work experience
- Experience of electronic device manufacturing – ideally electronic medical devices
- Experience managing supplier quality performance / supplier management experience
- Experience in fault finding/investigation
- Experience of working within a QMS driven environment
- Hands-on experience of implementing procedural changes
- Experience of working to ISO9001/ISO 13485
- Excellent written English and report writing skills
- Experience / understanding of FDA requirements (CFR 820) would be advantageous
- Excellent communication and presentation skills
Reporting to the Quality Assurance Manager, the successful Quality Engineer applicant will be providing support for all quality activities. Within this role the focus will be;
- Provision of support in the management of customer complaints
- Support CAPA management
- QMS performance review and input into improvements / changes
- Action issues arising from audits, complaints and non-conformities and identify opportunities for preventing and correcting further problems
- Provision of quality input into new product development and manufacturing activities
- Support calibration of R&D, test and manufacturing equipment
- Assist technical team in all quality matters relating to design, manufacture, suppliers and distribution of all medical devices
- Support management of suppliers
- Support all returns, complaints and post-market issues
- Support management with development of the Quality Program Plan and on-going maintenance
- Investigate product quality issues, determine root cause, analyse data and implement corrective actions
- Assist in records management and document control
- Support production activities from a quality perspective
- Support validation testing
- Perform internal audits
- Perform supplier audits
- Assist in development and delivery of internal quality training
Indo Professionals is a specialist medical device staffing business focused on placing high calibre professionals into regulatory affairs, quality assurance and clinical research positions UK wide. If you are looking for a new career challenge or would like a career consultation with an industry expert, please contact the team today.
Josh@indoprofessionals.co.uk / 01256 597 800