Our client, a leading global organisation based in West Sussex are currently looking for a Quality Assurance Engineer to assist the Quality Manager in the responsibility and upkeep of all company procedures to ensure it meets current CE and FDA requirements.

Our client is looking for individuals who are qualified to HND / Degree standard within a science or engineering related subject and can also demonstrate a minimum of 2 years commercial experience of working within a Quality Assurance environment, working to ISO 13485.

Individual's who possess lead auditing skills, have experience of working within a clean room and/or electronics environment within the medical devices or pharmaceutical industry together with knowledge of FDA standards would be of distinct interest to our client, though not essential.

The primary aspect of the role is assisting the R&D department with amendments to existing documents to ensure the smooth transfer from R&D to production as well as implementing new product documentation.

Key Tasks include:
* Maintenance of BS EN ISO 13485 Quality procedures and related records.
* Assisting and conducting internal and supplier Quality System Audits and follow up actions as required.
* Conduct risk assessments in partnership with the Regulatory Affairs and R&D Managers on all new product introductions.
* Follow up of corrective and preventive action plans raised from internal and external NCR's.
* Assisting the Quality Department in any BSI, FDA, CSA or other Notified Body, competent Authority and regulatory audits.

Our Client is offering a salary range of £25,000 - £30,000. 25 days holiday plus bank holidays with an option to purchase an additional 5 days a year through a salary sacrifice system. A PHI scheme which pays out 75% of the salary after 6 months of long term sickness. There is a share option scheme and the pension scheme is 4% contributable by employee and employer.

Ref no: CR-QAE-00B