Work as liaison between vendors and the organization. Assist in the identification, selection, and monitoring of vendors/suppliers. May create systems and procedures to ensure overall quality of vendor services. Facilitate development of relationships with vendors/suppliers; maintain relationships for long-term contracts; strive for continuous improvement; and to mediate performance and scorecard disputes. Participate in supply chain supplier quarterly business reviews with key suppliers. Assist in determining requirements for supplier assessments and certifications then ensuring supplier compliance to the defined requirements. Work under close to moderate supervision with moderate latitude for independent judgment. Consult with senior peers on non-complex projects to learn through experience.
Monitor and audit potential and existing suppliers. Develop component suppliers to ensure their ability to provide products that meet Mako quality standards. Facilitate root cause investigations concerning product non-conformances as they relate to suppliers. Document and trend supplier performance. Coordinate communications between assigned suppliers and Mako engineering department.
Bachelors degree in an engineering field, preferrably mechanical engineering; at least three years of experience in supplier relations; at least one year of experience in a supplier quality role .
Certified Quality Engineer (CQE)
Experience in the medical device industry, preferrably in the orthopediatic industry.
Knowledge of regulatory standards, FDA 21CFR 820, ISO 13485 or other quality system regulations.
Knowledge of inspection planning including inspection methodologies, test method validations.
Knowledge of Geometric Tolerancing (GD&T)
Knowledge of Coordinate Measuring Machine (CMM Inspection)
Experience in risk management specifically process FMEAs
Knowledge of methodologies for process verification and validations
Knowledge of statistical techniques