Quality Engineer

We at Orion Group are currently recruiting a Quality Engineer on behalf of one of our Multinational Medical Device Clients in Warwickshire to work on a 12-month contract.

SUMMARY
Responsible for maintaining the quality management system procedures for the facility. Administer Quality management system and corrective and preventive action system. Leading production projects, supporting validation and change management.

ESSENTIAL FUNCTIONS
* Provide Quality Engineering support to production for process improvement projects.
* Assist in the management of the CAPA system, Lead the investigation of non conformances, and lead the CAPA plan for timely closure
* Lead the development and evaluation of Statistical Process control within the manufacturing facility
* Create and maintain metrology programs for a range of precision metrology equipment Surface Finish Analyzer, Air Gages and inspection techniques such as, Roundness Testing, and coordinate measuring machines (CMM's)
* Monitor CER using calibrated gauging as per procedural requirements
* Control the gauge calibration system in both completing internal gauge calibration and arranging external calibration
* Performs and documents First Article Inspections Requirements (FAIR) on new products or after changes to a process
* Raise awareness of the Quality System and ensure that the requirements of the Quality System are observed

REQUIREMENTS
* Bachelor's degree in Engineering Licenses/Certifications Proven experience in project management
* Leading Validation projects in a high technology low volume manufacturing environment Skilled in Process and equipment Validation (eg. FAT, SAT, IQ, OQ and PQ) Lean and Six Sigma knowledge beneficial.

Experience
* Minimum 4 years experience in Medical Devices, regulatory affairs/compliance. ISO13485, FDA Competencies Communication, assimilation of data, working relationships across divisions.
* Ability to use MS Project, Word, Excel

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.