Staff QA Engineer

Dexcom • San Diego, CA

6d • $111,100 - $185,100

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

• Direct experience with Quality Management Systems, Nonconforming Material, CAPA, HHA/HHE, Nonconforming Events, Internal and External Audits.
• Good understanding of QMS as applied to medical devices.
• Direct experience developing dashboards in Power BI, Tableau.
• Experience with Oracle, Camstar, IQVIA, 1Factory, EtQ Reliance, SQL Servers, Google Big Query.
• Experience with statistical analysis and statistical analysis software packages like Minitab and Jump.
• Experience in FDA audits.
• Collaborative, able to work effectively and lead diverse functional groups.
• Demonstrates good judgment in selecting methods and techniques for problem solving and obtaining solutions.
• Can work well alone, normally receives little instruction on day-to-day work, general instructions on new assignments.
• A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.
• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 8-12 years related experience or Master’s degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.

Nice To Haves

• Certified Quality Engineer, Certified Quality Auditor a plus.

Responsibilities

• Defining requirements and development of analytic dashboards.
• Validating and deploying Quality Assurance data and information dashboards with focus on Manufacturing Controls, Quality Management Systems and New Product Development.
• Executing and coordinating Site Management Reviews for the San Diego site.
• Coordinating data transfer for Corporate Management Reviews.
• Leading and coordinating the Non-Conforming Events (NCE) system.
• Supporting Internal and External Audits.
• Providing Quality Assurance Engineering and Compliance expertise, and technical support to Sustaining Quality Engineering and Quality Control teams.
• Leading the design, development, validation, and deployment of Quality Assurance Metric Dashboards for all areas of Operations Quality Assurance in San Diego.
• Administering specific aspects of the quality system.
• Designing and applying company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations.
• Participating in internal and external audits to ensure systems comply with requirements and are effective.
• Participating as a member of design teams representing Quality Assurance.
• Coordinating the disposition of nonconforming materials with the Materials Review Board.
• Reading, writing, and understanding specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
• Working on QA Continuous Improvement Projects.
• Assuming and performing other duties as assigned.

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