Dexcom is looking to improve the quality of products from its suppliers and contract manufacturers by managing a team of quality engineers and ensuring successful validations, verifications, investigations, and qualifications.
Requirements
- Strong background in Process Quality Engineering
- Strong background in Process and/or Material Qualification
- Understanding and experience in PPAP
- Approval and qualification of new components and assemblies at suppliers. Qualification includes process validations consisting of IQ, OQ, and PQ.
- Responsible for non-conformance investigations for supplier issues, evaluating and approving corrective actions, and performing verification of effectiveness.
- Monitors trend data from suppliers and ensures proper corrective actions are implemented, when required.
- Responsible for understanding and complying with applicable quality (i.e. FDA, ISO), environmental and safety regulations. Responsible for assuring compliance to FDA QSR regulations.
Responsibilities
- Manages engineering team responsible for assuring high quality product from Dexcom suppliers and contract manufacturers.
- Approval and qualification of new components and assemblies at suppliers. Qualification includes process validations consisting of IQ, OQ, and PQ.
- Responsible for non-conformance investigations for supplier issues, evaluating and approving corrective actions, and performing verification of effectiveness.
- Monitors trend data from suppliers and ensures proper corrective actions are implemented, when required.
- Compiles statistical data and writes narrative reports summarizing quality findings and making recommendations.
- Drives process improvements to supplier qualification, validation, non-conformance, and maintenance processes and procedures.
- Responsible for understanding and complying with applicable quality (i.e. FDA, ISO), environmental and safety regulations. Responsible for assuring compliance to FDA QSR regulations.
Other
- Typically requires a Bachelor’s degree with 8- 12 years of industry experience
- 2-5 years of previous management or lead experience
- You build strong relationships with internal customers (i.e. Operations, Manufacturing, Sourcing, Quality)
- You communicate effectively with external customers (i.e. Suppliers, Contract Manufacturers)
- 25-50% Travel Required
