KMC Supplier Quality Assurance Lead – primary responsibility will be to establish, manage, and maintain the KMC Supplier Quality program including managing the KMC Supplier Approval and Assessment Process. Contributor to the selection and qualification of suppliers, includes conducting Supplier Audits and Managing the ASL. Develop purchasing control processes, procedures and systems in compliance with applicable medical device regulations. Owns supplier audit, monitoring, and assessments. Work closely with Sourcing colleagues in supplier selection/assessments, and Supplier classification and risk categorizations.
Actively monitors supplier quality agreements with critical suppliers and quality of supplier records and drives supplier quality management reviews with relevant stakeholders
Supplier Monitoring and Scorecard Tracking and reports supplier related metrics to ensure compliance with performance criteria and pursues corrective actions as required.
Handling and Coordination of the NCMR – MRB process controls and communication actions including SCARS with Suppliers.
The ideal candidate will have 10 years relevant FDA QMS/Supplier Quality experience and a Bachelor’s degree in related field. Prior FDA and/or ISO 13485 experience is a must.
Ability to establish strategic Q&R programs and develop and implement plans efficiently and effectively. ASQ Certified Auditor preferred.