Senior QA Engineer

Dexcom • San Diego, CA

1d • $87,000 - $145,000

About The Position

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. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: 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. Where you come in: The Senior level Supplier Quality Engineer engages suppliers in three fundamental means: Supplier evaluation to drive supplier assessments to determine supplier abilities to meet Dexcom requirements. Material qualification to drive material assessments to determine conformance to requirements. Supplier development to improve capabilities of key suppliers and/or materials.

Requirements

• Possess manufacturing experience in the following processes: Injection molding Electronics (PCB and PCBA manufacturing) Battery Assembly
• Possess knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards (e.g. ISO 13485).
• 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.
• Works and communicates effectively and professionally in a team environment with minimal supervision.
• Ability to manage shifting priorities with minimal difficulties.
• Applies proficient computer skills in the use of Microsoft Office and database applications.
• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.

Nice To Haves

• Certified or trained to perform quality audits is highly desired.

Responsibilities

• Perform supplier qualification audits, monitor supplier performance, provide information for supplier program metrics and periodic reports, and assist in management of the supplier corrective action system.
• Maintains the Supplier Audit Schedule and ensures compliance with this schedule.
• 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 type of 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.
• Conducts failure investigations as needed
• Maintain 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.
• Assumes and performs other duties as assigned.
• Provides training and guidance to lower level quality engineers and new hires.
• 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.

Benefits

• 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 in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level