This innovative and forward thinking leader in non-toxic, environmentally friendly sterilisation systems is heading for exciting times. With an outstanding product and a fantastic team, this is a great opportunity to join a company which is really going places.
An experienced Quality Manager is required to oversee:
Manufacturing Quality Engineering - Support manufacturing on all issues that relate to Quality System Requirements implementation, interpretation, and enforcement. Working with manufacturing to improve the quality yielded from manufacturing processes by introducing, making and implementing automation as appropriate, refining processes and documentation and procedures;
Development Quality Engineering - Provide technical support related to Reliability Engineering and device testing. Developing a greater emphasis on Design for reliability within the development activities; Assisting with the planning and conducting of all qualification tests and assure compliance with regulatory test requirements; Supporting the Design Control process to increase both efficiency and compliance; Assuring controlled documentation is current and correctly implemented.
Supplier Quality Engineering - Support Manufacturing, Purchasing, and Development Engineering on the implementation and maintenance of a Supplier Quality Management Program. Providing support to appropriate measures, reviews, approval processes, and quantitative goals of the Supplier Quality Management Program; Working closely with Development Engineering during the early phases of product design to ensure that suppliers are appropriately chosen based on capability and desire to meet quality requirements; Administering the Approved Vendor List and Vendor Corrective Action initiatives.
Failure Analysis Engineering - Act as the primary focus responsible for failure analysis of field failures. Work closely with Product Management to ensure FDA MDR requirements are met in a timely manner. Perform and/or coordinate failure analysis down to component level; Create reports for inclusion in complaint files and facilitate resolution and closure of files; Identify corrective action related to device field failures.
This role calls for a hands on approach. The ideal candidate will be highly organised with a logical and practical aptitude. You should be a team player with solid man management skills and have relevant qualifications/experience in engineering and quality control.
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