Location: Cambridge (CB3) Duration: Permanent Hours: 37.5 per week (Monday to Friday) Salary: Up to £55,000 per annum share options Job Reference: 35594 Polytec are looking for an experienced Quality Engineer to join our Cambridge based client. The successful candidate will be responsible for supporting our client scale-up their production operations as well as ensuring their products are compliant with international regulations so they are able expand into foreign markets. Responsibilities: Obtain and maintain product compliance across UK, US and Europe markets Implement a company wide QMS system Prepare and maintain documentation such as technical files and batch records Implement and monitor quality control systems to ensure product quality meets the US market's specifications Perform quality audits and manage internal audits to assess adherence to US regulatory standards and best practices Lead corrective and preventive actions (CAPA) for non-conformances Develop and maintain test plans, inspection procedures and other quality documentation required for US regulatory compliance Own the Engineering Change Request process to ensure design control and ongoing instrument compliance Participate in design reviews, DFMEA and PFMEAs to ensure regulatory requirements are met early in the development process Requirements: Relevant degree or apprenticed to HNC level with additional training 5 years experience as a Quality Engineer in an applicable industry Understanding of UK, US and EU compliance Good technical knowledge of quality management Knowledge of ISO9001 or UL61010 standards Please contact us as soon as possible for more details or apply below