Validation Engineer-Cambridgeshire – Medical Devices

My client is an innovative and exciting new start-up within the Cambridgeshire area. They are looking to expand their Quality Assurance team size with a talented, confident, and expereinced Validation engineer. Working to develop and manufacture a point of care molecular diagnostics device. We are looking for an individual experienced within the IVD and or medical devices industry, with a minimum of 3 years’ experience in validation.

Preferred Knowledge & Experience: * Provide the support and expertise to company R&D, manufacturing and QC teams in the validation of new and updated processes at all operational sites (currently two sites).

* Prepare validation plans and reports for internal company processes by interfacing with manufacturing and QC teams.

* Effectively liaise with contract manufacture partners on ensuring external processes meet company and quality requirements.

* Ensure equipment calibration and maintenance processes are implemented, maintained, compliant and effective.

* Assist with NC and CAPA investigations relating to manufacturing, QC and equipment.

* Prepare and implement quality system procedures, work instructions to required international/national standards.

* Working as part of the Quality Assurance team in promoting the quality culture, maintaining quality metrics and contributing to the development of the quality strategy.