Responsible for ensuring compliance of Intuitive's Supplier Controls with applicable regulations and standards including ISO 13485:2016, MDSAP, and EU MDR, partnering with cross-functional teams to improve Supplier Controls Business Processes.
- Conduct assigned Supplier Audits as Lead Auditor per Global Supplier Audit Schedule
- Execute Audit Reports with necessary Audit Response Forms and Supplier Responses
- Own Supplier Quality processes including Supplier Controls, Global Supplier Manual, Supplier Selection, Evaluation and Re-Evaluations, SCAR Process, and Supplier Monitoring as a Corporate Business Process Owner
- Run quarterly Supplier Monitoring Boards with cross-functional stakeholders
- Periodically analyze and review Supplier Controls processes in partnership with Regulatory Affairs/Quality Systems team to maintain compliance with latest applicable Regulations and Standards
- BS degree in Engineering or equivalent
- Nice to have: Master's degree in Engineering or related field
- Nice to have: Certified Lead Auditor for EUMDR
- Nice to have: QMSR knowledge
Site Operations & Business Enablement LeadNewZimmer US, Inc. · Salt Lake City, US