Sr QA Engineer

Meet the team:

Join us in empowering people to take control of their health! You will join a collaborative team at the heart of Dexcoms products. Our quality engineering team plays a crucial role in global crosssite and crossfunctional alignment for the future of Dexcom and for the future of our customers health. You will support Dexcom in bringing stateoftheart innovative technology to patients and will help define support and improve the processes that get us there.

Where you come in:

• You actively participate as a core team member for new manufacturing automation equipment development teams. Duties include providing technical team regulatory guidance ensure adherence to Quality Management System help define equipment requirements aid with process development develop risk assessment participate in concept and design reviews develop equipment qualification and process validation strategy support equipment buyoff activities at vendor site(s) support Process Validation activities at Dexcom manufacturing site(s) demonstrate product/process specifications are met and maintained.
• You act as subject matter expert to help develop and support equipment qualification and process validation (SW validation IQ TMV OQ PQ process monitoring) activities.
• You support new manufacturing process development and provide sustaining quality engineering support during initial commercial implementation of a new process. Duties include assisting root cause investigation initiation and disposition of nonconforming materials with the Materials Review Board equipment and process improvement changes.
• You lead multilevel crossfunctional and international crosssite alignment on complex topics and provide direction with strong critical thinking.
• You improve over time and ensure continued adherence to Quality Management System and risk management procedures to help Dexcom maintain its quality policy and compliance with domestic and international regulations.
• You participate in internal audits and audits done by external regulatory bodies to ensure quality management system complies with regulatory requirements.

What makes you successful:

• You have experience and application of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems).
• You are proficient with reading writing and reviewing extensive technical documentation drawings and specifications.
• Your proficient with root cause analysis six sigma structured problem solving test method validation software validation process validation process capability measurement (Cpk) lean manufacturing sampling plans and statistical analysis.
• You have computer and data analysis skills in the use of Microsoft Office and other applications e.g. Excel JMP MiniTab.
• You have excellent communication (written and oral read/write/interpret) skills.
• You can organize and prioritize assignments providing direction to and participation in assigned cross functional teams.
• You bring initiative and integrity to drive identification assessment and corrections for compliance and procedural gaps.
• You can work in a dynamic work environment and perform other duties as assigned.

What youll get:

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through inhouse learning programs and/or qualified tuition reimbursement.
• An exciting and innovative industryleading organization committed to our employees customers and the communities we serve.

Travel Required:

• 515