Staff QA Engineer

Dexcom • San Diego, CA

3d

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: Join us in empowering people to take control of their health! You will join a collaborative team at the heart of Dexcom’s products. Our quality engineering team plays a crucial role in cross-site and cross-functional alignment for the future of Dexcom and for the future of health. You will support Dexcom in launching state-of-the-art innovative technology and will help define, support, and improve the processes that get us there. Where you come in: You offer expertise in chemistry, polymers/polymer manufacturing, scale-up, and/or analytical test method validation, including but not limited to GPC, HPLC, FTIR. You apply your hands-on experience with high volume manufacturing in medical device, biosensor, or similarly regulated industry and are seen as a quality leader, performing strategic work with minimal direction needed from management. You provide leadership and technical guidance for strengthening of and adherence to the Quality Management System (Failure Model Effects Analysis (FMEA), qualification and validation requirements, CAPAs, NCMRs, Process Controls). You lead multi-level, cross-functional, and international cross-site alignment on complex scientific topics and provide direction with strong critical thinking and excellent personal and communication (written and oral, read/write/interpret) skills. You create strong partnerships with R&D, Regulatory Affairs, Customer Advocacy, Process Engineering, Manufacturing, Equipment Engineering, Maintenance teams and more. You apply your expertise in risk-based decision-making to manage Risk/Impact assessments during various phases of design controls (use of novel materials, change control, validation, monitoring plans, sampling plans, sample size, non-conformances), providing solutions that align with risk. You support root cause analysis, six sigma, structured problem solving, Test Method Validation (including but not limited to Gage R&R), software validation, process capability measurement (Cpk), lean manufacturing, and statistical analysis. You take initiative to drive identification, assessment, and corrections/corrective actions/preventive actions for compliance and procedural gaps.

Requirements

• Chemical Engineering, Chemistry, or similar degree from accredited College/University and your expertise in biosensors, chemistry, and polymers, and complex analytical methods as they relate to manufacturing and material/process characterization.
• Familiarity with Medical Device, Pharmaceutical and/or Combination Product requirements, e.g. 21 CFR 4, 10, 11, and 820, USP, ISO 13485, EU MDR.
• Six Sigma, Lean manufacturing, and/or sustaining experience supporting process characterization, and improvements.
• Expertise with quality engineering tools for statistical data analysis, sampling plan development, sample size determination, AQL, confidence intervals, etc.; Statistical Software (e.g. JMP) experience and six sigma green belt certification(s) preferred.
• Competency in Root Cause Analysis and Structured Problem Solving to help resolve process inefficiencies.
• Passion to improve systems and processes that increase product safety, consistency, and conformance to requirements.
• Inquisitive, investigative, detailed approach and agility to be “in the weeds” technically while being an effective part of the QA strategic team.
• Proficiency in communicating technical information in a clear and concise manner, driving understanding and consensus.
• Skill interpreting and assessing sources of variation for complex measurement methods using MSA/ANOVAs and statistical data analysis from process validation/monitoring.
• 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

• Statistical Software (e.g. JMP) experience and six sigma green belt certification(s) preferred.

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