434 quality systems jobs at 255 companies in San Jose, CA
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Quality Systems Specialist
Redwood City, California, United States
$87k-$100k/yrOnsiteFull Time
Element Science: Develops wearable patch defibrillators for high-risk cardiac patients.
3+ YOEBachelor's degree in science, engineering, or related field; 3+ years in medical device quality systems; knowledge of ISO 13485 and QMSR; strong analytical, organizational, communication, and collaboration skills.
Propel, electronic quality management system (eQMS)
OlympusTokyo Stock Exchange: 7733: Manufactures medical endoscopes and minimally invasive surgical tools.
5+ YOEBachelor's in engineering/life sciences/quality/regulatory; 5+ years in quality systems or related field; QMS/ISO 13485/21 CFR Part 820 knowledge; audit, CAPA, change control, risk management, technical writing, and stakeholder leadership skills.
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
5+ YOEBachelor’s degree in engineering; 5+ years in engineering with quality tools; knowledge of FDA 21 CFR 820, ISO 13485; CAPA/quality systems experience.
AppleNASDAQ: AAPL: Designs and sells consumer electronics, software, and online services.
Experience validating and documenting software systems against specified requirements and regulatory standards across product development, manufacturing, and business operations.
SupermicroNASDAQ: SMCI: Designs and manufactures high-performance server and storage solutions.
2+ YOEBachelor's degree required, 2+ years supporting QMS/EMS/ISMS in manufacturing or high-tech, ISO standard knowledge, audit and document-control experience, Internal/Lead Auditor preferred, Microsoft Office proficiency.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, document management systems
Noctrix Health: Develops wearable therapeutic devices for chronic neurological disorders.
3+ YOEAssociate's or bachelor's degree and 3+ years in document control, quality systems, training administration, or quality assurance in a regulated industry. Requires eQMS, FDA, ISO 13485, records, and audit experience.
electronic Quality Management System (eQMS), Microsoft Office, Arena
Senior Systems Quality Engineer (Integrated System Test, Sunnyvale)
Sunnyvale, California, United States
OnsiteFull Time
TeradyneNASDAQ: TER: Designs and manufactures automated test equipment and advanced robotics systems.
10+ YOEBachelor's degree in a technical field and 10+ years in quality engineering, software testing, systems validation, or related engineering. Requires C# or C++, Python, PowerShell, or Bash, CI/CD, system testing, and leadership experience.
Align TechnologyNASDAQ: ALGN: Designs and manufactures clear aligners and intraoral scanners.
6+ YOEBachelor's in engineering/life sciences, 6+ years QMS/quality engineering experience in medical devices, internal/external audit experience, knowledge of ISO 13485 and risk management, eQMS experience, strong problem-solving and communication.
Associate Director, Quality Systems Monitoring & Excellence
Redwood City, California, United States
$186k-$233k/yrHybridFull Time
Revolution MedicinesNASDAQ: RVMD: Developing precision oncology therapies for RAS-addicted cancers
10+ YOEBachelor's degree in a scientific discipline, 10+ years of Quality Assurance or Quality Systems experience with people leadership, global GxP expertise, inspection and audit leadership, and eQMS experience.
Electronic Quality Management Systems (eQMS), Veeva Vault, AI, automation, data analytics, digital Quality platforms, executive dashboard
QualcommNASDAQ: QCOM: Designs and manufactures semiconductors and wireless telecommunications products.
Requires a master's degree in electrical engineering, computer engineering, computer science, or related field; expertise in Wi-Fi systems testing, automation, interoperability, log and packet analysis, and defect troubleshooting.
Calista Brice: Provides specialized construction and environmental services in remote regions.
5+ YOEBachelor’s degree in Engineering, Architecture, or Construction Management; 5 years in QC management or 10 years in construction management; USACE CQM certification or ability to obtain within 90 days; valid driver's license.
QuantumScapeNYSE: QS: Develops next-generation solid-state batteries for electric vehicles.
12+ YOE3+ Mgmt12+ years quality experience in regulated, high-volume manufacturing with 3+ years management; deep ISO 9001 and IATF 16949 QMS expertise; lean, CAPA, internal audit, CRB/MRB, and strong cross-functional communication.
PLM-Vault, 8D, FMEA, SPC, MSA, APQP, PPAP, IQC, control plans
Sr. Manager, Quality Systems and Regulatory Compliance
Pleasanton, California, United States
OnsiteFull Time
Albertsons CompaniesNew York Stock Exchange: ACI: Operates supermarkets and pharmacies across the United States.
Lead quality systems and regulatory compliance activities, partner with stakeholders to drive improvements, and support training and policy implementation across operations.
Rondo Energy: Manufactures thermal batteries for industrial zero-carbon heat delivery.
4+ YOEBachelor's in Electrical Engineering, ~4–12 years supplier/manufacturing quality experience with electrical components, supplier audits, root cause analysis (8D/A3/5 Why), and willingness to travel internationally up to 75%.
APQP, PPAP, PFMEA, Control Plans, SPC, MSA, ISO 9001, First Article Inspection (FAI)
BridgeBio PharmaNASDAQ: BBIO: Discovers and develops medicines for patients with genetic diseases.
8+ YOEBachelor's in pharmacy/science/math/engineering,8+ years QA experience in biotech/pharma,expertise in ICH Q9 and FMEA,risk management,APQR compilation,eQMS/Veeva proficiency,regulatory knowledge (FDA,ICH,EU GMP).
eQMS, Veeva Vault, Microsoft Office, Microsoft Excel, Google Docs
VeecoNasdaq: VECO: Manufactures precision processing systems for semiconductor and electronics production
10+ YOE2+ MgmtBachelor's in engineering, 10+ years supplier/manufacturing/quality experience, 2+ years people leadership, expertise in supplier quality systems (PQP, PFMEA, SPC, MSA), and structured problem solving (8D, A3, DMAIC).
Verily: Developing data-driven technologies for clinical research and precision health.
8+ YOEBachelor's plus 8+ years in quality/regulatory for medical device or digital health, ISO 13485 and FDA QMSR experience, CAPA/risk management per ISO 14971, IEC 62304, SaMD/AI/ML quality experience, QMS leadership and team development.
Matternet: Develops autonomous drone networks for urban package delivery.
4+ YOERequires 4+ years in quality engineering for complex hardware with embedded software, certified quality-system leadership, 8D/DMAIC nonconformance management, NPI quality expertise, statistical analysis, and a BS in Engineering or related field.
8D, DMAIC, PFMEA, Tableau, JIRA, Confluence, Slack, Google Docs, Google Sheets, Google Slides, Arena PLM, FSA, MRB, AS9100, ISO9001, DO-178C, Safety Management Systems (SMS)
Applied MaterialsNASDAQ: AMAT: Produces equipment and services for chip and display manufacturing.
Develop and maintain quality and reliability standards; perform testing, failure analysis, and reliability modeling; coordinate with suppliers and engineers.