Sr QA Engineer

Dexcom • Mesa, AZ

1d • Onsite

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.

Requirements

• Possess an in-depth and professional level of knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards including ISO 13485 & ISO 14971.
• Effectively utilizes knowledge of techniques such as: six sigma methodologies, gauge R&R studies, process capability (Cpk/Ppk), lean manufacturing, sampling plans, and statistics.
• Strong background in any of the following processes: Injection molding, Extrusion, Stamping, Electronics (PCB and PCBA manufacturing), Wire manufacturing, Machining and Assembly.
• Excellent communications and collaboration skills with internal and external teams including quality engineering, manufacturing, receiving inspection and supplier representatives.
• Ability to manage work and shifting priorities in a fast-paced manufacturing environment.
• Previous medical device experience in quality engineering or supplier quality.
• Previous training and/or certification for quality audits.

Responsibilities

• Approval and qualification of new components and assemblies at suppliers.
• Qualification includes process validations consisting of IQ, OQ, and PQ.
• Assess quality performance issues of suppliers using multiple input data streams from Dexcom and the supplier’s process to drive / support supplier development activities.
• Responsible for non-conformance investigations of supplier issues, evaluating and approving corrective actions, and performing verification of effectiveness.
• Take the initiative to develop systems and processes that improve product safety; increase product consistency and conformance to requirements; maintain the supplier quality system, improve production efficiency; reduce operating and scrap costs.
• Work cross-functionally to track and trend supplier improvements and ongoing projects.

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: Senior
• Number of Employees: 5,001-10,000 employees