Sr QA Engineer

Sr QA Engineer

Requirements

• Experience and application of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems
• Proficient with reading, writing, and reviewing extensive technical documentation, drawings, and specifications
• 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
• Computer and data analysis skills in the use of Microsoft Office and other applications e.g. Excel, JMP, MiniTab
• Excellent communication (written and oral, read/write/interpret) skills
• Ability to organize and prioritize assignments providing direction to and participation in assigned cross functional teams
• Initiative and integrity to drive identification, assessment, and corrections for compliance and procedural gaps
• Ability to work in a dynamic work environment and perform other duties as assigned

Responsibilities

• Actively participate as a core team member for new manufacturing automation equipment development teams, providing technical team regulatory guidance, ensuring adherence to Quality Management System, helping define equipment requirements, aiding with process development, developing risk assessment, participating in concept and design reviews, developing equipment qualification and process validation strategy, supporting equipment buyoff activities at vendor site(s), supporting Process Validation activities at Dexcom manufacturing site(s), demonstrating product/process specifications are met and maintained
• Act as subject matter expert to help develop and support equipment qualification and process validation (SW validation, IQ, TMV, OQ, PQ, process monitoring) activities
• Support new manufacturing process development and provide sustaining quality engineering support during initial commercial implementation of a new process, including assisting root cause investigation, initiation and disposition of nonconforming materials with the Materials Review Board, equipment and process improvement changes
• Lead multi-level, cross-functional, and international cross-site alignment on complex topics and provide direction with strong critical thinking
• 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
• Participate in internal audits and audits done by external regulatory bodies to ensure quality management system complies with regulatory requirements

Preferred Qualifications

No preferred qualifications provided.