Senior QA Engineer

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream:
To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Now 25 years later, we have pioneered an industry and we’re just getting started. We are broadening our vision beyond diabetes to empower people to take control of health, delivering personalized, actionable insights to solve important health challenges. We continue to improve human health.

Welcome to our Supplier Quality team! We are a dedicated group of professionals committed to ensuring the highest standards of quality in our supply chain. Our team is passionate about fostering strong relationships with our suppliers and driving continuous improvement in all aspects of supplier quality.

The Senior level Supplier Quality Engineer engages suppliers in three fundamental ways:

• Supplier evaluation to drive assessments that determine suppliers’ abilities to meet Dexcom requirements.
• Material qualification to assess conformance to requirements.
• Supplier development to improve capabilities of key suppliers and/or materials.

• Possess manufacturing experience in the following processes:
  • Injection molding
  • Electronics (PCB and PCBA manufacturing)
  • Battery
  • Assembly
• Perform supplier qualification audits, monitor supplier performance, provide information for supplier program metrics and periodic reports, and assist in managing the supplier corrective action system. Possess knowledge of the Quality Systems Regulations 21
  
  CFR Part 820 and international quality systems and medical device standards (e.g. ISO 13485). Certified or trained to perform quality audits is highly desired. Maintains the Supplier Audit Schedule and ensures compliance with this schedule. May attend and support internal audits by regulatory and other outside agencies.
• Establishes and maintains supplier Quality Agreements, where needed, and any joint periodic supplier business reviews. Reviews and approves supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreements.
• May work as a member of the design team, as required. Some activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs. Reads, writes, and understands specifications and inspection criteria. Reads schematics and mechanical drawings and provides input into revisions, as needed. Has understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).
• Possesses knowledge of techniques like Six Sigma, Gage R&D studies, process capability measurement tools (Cpk), lean manufacturing, sampling plans and statistics.
• Takes the initiative to improve systems and processes that increase product safety; increase product consistency and conformance to requirements; improve production efficiency and communication; reduce operating and scrap costs. Conducts failure investigations as needed.
• Maintains the supplier quality management system according to written policies and procedures. Will provide key input on compliance and continuous improvement of business processes. Works cross‑functionally to track and trend supplier improvements.
• Works and communicates effectively and professionally in a team environment with minimal supervision. Assumes and performs other duties as assigned. Ability to manage shifting priorities with minimal difficulties. Provides training and guidance to lower level quality engineers and new hires. Applies proficient computer skills in the use of Microsoft Office and database applications.
• Assesses quality performance issues of assigned suppliers using multiple input data streams from Dexcom and the supplier’s process to drive / support supplier development activities. Performs process evaluation of key processes of assigned suppliers to drive / support supplier development activities.

• A front row seat to life‑changing CGM technology and the brave…