Sr Quality Engineer, Supplier Quality Engineering

Dexcom is a global leader in continuous glucose monitoring. The Supplier Quality department ensures that externally sourced components and materials meet stringent quality and regulatory standards in the medical industry. This position partners with global suppliers, drives quality performance, and facilitates continuous improvement initiatives to support product reliability, patient safety, and supply chain integrity.

Responsibilities

Design and maintain supplier quality management system according to written policies and procedures; Provide quality guidance to other departments; Perform supplier qualification audits, monitor supplier performance, provide supplier program metrics and periodic reports, and manage supplier corrective action system; Establish and maintain Supplier Audit Schedule and ensure compliance; Attend and support internal audits by regulatory and outside agencies; Serve as supplier quality representative during internal audits and for designated suppliers; Chair Supplier Review meetings and ensure supplier program transparency and open communication; Establish and maintain supplier Quality Agreements and joint periodic supplier business reviews; Review and approve supplier documentation (protocols, reports, specifications, etc.); Possibly work as a member of the design team; Provide training and guidance to lower-level quality engineers and new hires; Develop systems and process improvements that increase product safety, consistency, production efficiency, and reduce operating and scrap costs; Revise DFMEA and PFMEA if necessary; Possible domestic and international travel

Requirements

Demonstrated mastery of structured problem-solving methodologies (e.g., 8D, 5 Why, Ishikawa), with a proven track record of leading complex cross-functional investigations; Extensive experience conducting and leading supplier, certification, and regulatory compliance audits; Strong understanding of end-to-end manufacturing processes, preferably including molding, metal processing, ultrasonic cleaning/welding, SMT operations, and power electronics production; Highly proficient in data-driven decision-making and trend analysis; Exceptional communication and stakeholder management skills; Proven expertise in applying advanced quality tools such as APQP, PPAP, SPC, MSA, and FMEA; Knowledge of Good Documentation Practices (GDP); Deep understanding of ISO 13485 or comparable regulated quality management systems; Knowledge of Quality Systems Regulations 21CFR Part 820; Proficiency with Microsoft Office and database applications (such as Oracle, SAP and Minitab); Ability to read, write and understand specifications, inspection criteria, schematics and mechanical drawings

Nice to have

Training and/or certification to perform quality audits is highly desired; Experience with supplier quality programs is highly desired; Certification or formal training in quality auditing