Quality Engineer

As a high-tech specialist and world market leader, our client are synonymous with innovative medical technology. The group of companies combines core fields of expertise: research and development, production and service as well as distribution and training.
Job Purpose:

To perform vendor quality engineering activities supporting safe, effective and compliant development and sustainment of the organisations medical device designs and manufacturing processes

Your duties:

Establish, maintain and execute the means of evaluating,(including site auditing),;the quality/regulatory aspects of vendor control to maintain a compliant approved external supply base in the best commercial interests of the company
Co-ordination, review and approval of internal and external component qualification effort, including coordinating conduct of; metrology, measurement system analysis and capability assessments; to ensure ongoing confidence that all externally supplied componentry meets predefined design requirements, in a compliantly documented manner
Co-ordinate the supplier corrective action request system to ensure the timely resolution and closure of vendor related quality issues
Support vendor communication and improvement activity, using problem solving tools, to continuously improve the quality and cost of vendor supplied product and service
Compile and interpret metrics relating to vendors quality performance; to support provision of vendor performance analysis to top management
Support the Quality Engineering Manager coordinating tasks and supervision of resource to optimise the effectiveness of quality engineering
Education/Qualification

HND equivalent calibre in engineering, science or technology discipline
Lead Auditor qualification (ISO 9000 series based quality system essential, ISO13485 preferred)
Skills/Work Experience

of a quickly evolving environment with cross functional team working
Ability to interpret; technical standards, technical drawings and specifications with a good understanding of metrology and other measurement considerations
Excellent report writing and presentation skills, good verbal communication skills
Experience in a range of statistical techniques including; sampling techniques, MSA, capability analysis etc; experience of using applicable s/w applications advantageous
Experience of risk management techniques including FMEA
Exposure to common formal problem solving techniques