115 applicants
Dexcom · 19 hours ago
Sr QA Engineer
San Diego, CA
Full-time
Onsite
Senior Level
$87K/yr - $145K/yr
5+ years exp
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Insider Connection @Dexcom
Responsibilities
Apply expertise in root cause analysis, six sigma, structured problem solving, Test Method Validation, process capability measurement tools, lean manufacturing, sampling plans, and statistics.
Lead complex NCMRs/CAPAs and the creation of/improvement to the Quality Management System, qualification/validation requirements, SOPs, process controls, and FMEAs.
Champion multi-level, cross-functional, and international cross-site alignment on complex scientific issues and provide direction with strong communication (written and oral) and excellent interpersonal skills.
Partner with various teams including R&D, Regulatory Affairs, Customer Advocacy, Process Engineering, Manufacturing, Equipment Engineering, Maintenance, etc.
Drive identification, assessment, and corrections for compliance and procedural gaps.
Oversee clean room area audit readiness and implement tools where necessary to support and strengthen.
Assess and manage the impact of change control to products, qualified systems, SW, and validated processes to ensure product safety and compliance.
Develop systems and processes that improve product safety, increase product consistency, improve product efficiency, reduce operating and scrap costs, and maintain conformance.
Qualification
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Required
Your Chemical Engineering or similar degree from accredited College/University.
Your familiarity with Pharmaceutical and/or Combination Product requirements, e.g. 21 CFR 4, 11, and 820, USP, ISO 13485, EU MDR.
Your hands-on experience with risk management and risk-based decision-making in high volume manufacturing in pharmaceutical, combination product, medical device, and/or biosensor industries.
Your proficiency with quality engineering tools including statistical data analysis, sample size requirements, sampling plans, AQL, confidence intervals, etc.; JMP experience and six sigma certification(s) preferred.
Your experience with chemistry, polymers, and complex analytical methods as they relate to manufacturing and material/process characterization.
Your interest in being “hands-on” and on the manufacturing floor to learn new technologies/processes, assess risk, and troubleshoot.
Your competency in assessing and documenting risk during various phases of design controls and in providing solutions to address risk while moving new products and processes to commercialization.
Your agility to balance independent work with program alignment, implementing efficient and effective communications and problem solving cross-functionally with both small and large groups.
Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related experience
Preferred
JMP experience and six sigma certification(s) preferred.
Benefits
Comprehensive benefits program
Global growth opportunities
Career development programs
Tuition reimbursement
Innovative work environment
Company
Dexcom
Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.
5,001-10,000 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
Trends of Total Sponsorships
2023 (52)
2022 (55)
2021 (62)
2020 (48)
Funding
Current Stage
Public CompanyTotal Funding
$2.16BKey Investors
RWI Group
2023-05-02Post Ipo Debt· $1B
2020-05-12Post Ipo Debt· Undisclosed
2018-11-01Post Ipo Equity· $750M
Leadership Team
Matt Dolan
Executive Vice President, Strategy, Corporate Development & Dexcom Labs
Teri Lawver
Executive Vice President and Chief Commercial Officer
Recent News
2024-06-05
2024-06-05
Company data provided by crunchbase
