Dexcom · 1 day ago
Staff QA Engineer
San Diego, California
Full-time
Onsite
Senior Level, Lead/Staff
$111K/yr - $185K/yr
5+ years expDexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). The Staff QA Engineer will support the launch of innovative technology and enhance quality management processes across the organization, leveraging expertise in chemistry and quality engineering.
DiabetesHealth DiagnosticsMedical DeviceSensor
Responsibilities
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
Qualification
Required
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
Your 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
Your familiarity with Medical Device, Pharmaceutical and/or Combination Product requirements, e.g. 21 CFR 4, 10, 11, and 820, USP, ISO 13485, EU MDR
Your Six Sigma, Lean manufacturing, and/or sustaining experience supporting process characterization, and improvements
Your 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
Your competency in Root Cause Analysis and Structured Problem Solving to help resolve process inefficiencies
Your passion to improve systems and processes that increase product safety, consistency, and conformance to requirements
Your inquisitive, investigative, detailed approach and agility to be 'in the weeds' technically while being an effective part of the QA strategic team
Your proficiency in communicating technical information in a clear and concise manner, driving understanding and consensus
Your 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
Benefits
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.
Company
Dexcom
Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.
10001+ employees
H1B Sponsorship
Dexcom has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (41)
2023 (67)
2022 (75)
2021 (49)
2020 (36)
Funding
Current Stage
Public CompanyTotal Funding
$2.16BKey Investors
RWI Group
2023-05-02Post Ipo Debt· $1B
2020-05-12Post Ipo Debt
2018-11-01Post Ipo Equity· $750M
Leadership Team
Jake Leach
Chief Operating Officer
Matt Dolan
Executive Vice President, Strategy, Corporate Development & Dexcom Labs
Recent News
The Motley Fool
2025-12-30
Company data provided by crunchbase