ORTHOFIX

Quality Operations Manager Bussolengo

We offer an interesting opportunity to join our Quality Operations team, based in Bussolengo (VR) a Quality Operations Manager, reporting to the Senior Quality Manager Europe. The person will coordinate a team and he/she will be responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. He/she interacts with many different functional departments, suppliers, and experts outside Orthofix to implement Orthofix Quality goals. The person provides Quality support for the design transfer of orthopedic implants and related instrumentation, development, and improvement of associated manufacturing processes. This involves working closely with Operations and Product Development on new product development teams, and active participation to support product and process design, development, and validation activities. Responsibilities: Coordinate the Team Quality Operations defining goals, objectives and priorities.Responsible for assuring products conformity to established requirements and standards through appropriate audit, inspection, and testing activities. Participate in internal and external process quality audits.Coordinate process FMEA team, review and approve documented FMEA results.Participate in design reviews at various levels to communicate product and process non-conformity and failure trends and make recommendations for future designs.Develop, implement, and improve overall quality systems Validation protocols and production control plan, including quality standards, and reviewing documents and reports to ensure safety, reliability and efficacy of new products/processes and significant changes related to existing devices.Assist in development, review and approval of process and equipment validation/qualifications.Define and approve product/process inspection plans and documents.Work closely with Op