A world leading Medical Device manufacturing organisation, based in the Hampshire area, are currently recruiting a Senior R&D Quality Engineer to join the Quality Assurance R&D team, on a permanent basis.
The core function of the role is to be responsible for leading QA Activities in Concept Research Control or Design Control activities, Risk Management in the R&D and Manufacturing areas. You will ensure that clinical trial samples, new products and new processes meet all regulatory requirements.
Other key responsibilities include:
Maintain and update global procedures for Design Control and Risk Management that adheres to, ISO 13485, ISO 14971, MDSAP and MDD/ MDR.
Lead and review Concept Research Control or Design Control activities for clinical trial sample production, new products or process development, during all control phases, including design reviews, design, design change, design history files, and associated risk management activities.
Support R&D in the development of the inspection methodology and acceptance criteria for sampling plans, including the incoming, in-process, final, and validation sampling plans as part of the design development process.
Works closely with Regulatory Affairs, and Research and Development functional groups, to ensure compliance to applicable standards
Supports Manufacturing in Validation and Control Planning.In order to be considered for the role candidates need to have a degree in a suitable Engineering or Scientific discipline. In addition to this it is important individuals have experience working within a similar process manufacturing industry in the QA department. Candidates ideally would have NPI / NPD (New Production Introduction / Development) knowledge and strong risk management experience. Previous experience with ISO13485 or MDR/MDD would be a distinct advantage. GMP experience is also essential.
This is an excellent opportunity for a Senior R&D Quality Engineer within a rapidly expanding and innovative organisation offering a competitive salary, plus 25 days holiday, Pension Scheme, Healthcare, plus relocation assistance for the right candidate.
This role is based in Hampshire and commutable from, Portsmouth, Fareham, Gosport, Southampton, Havant, Alton, Winchester, Basingstoke, Andover, Salisbury.
To apply, please email your CV to or click "apply".
STR Limited is acting as an Employment Agency in relation to this vacancy