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