614 senior quality engineer jobs at 306 companies in Berkeley, CA
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Senior Quality Engineer
Santa Clara, California, United States
$140k-$150k/yrOnsiteFull Time
Picarro: Manufacturer of high-precision gas and isotope analysis instruments.
5+ YOE5+ years quality engineering in high-tech manufacturing, BS in relevant engineering, ISO 9001 experience, FMEA/CAPA/8D, supplier quality, data analysis, and proficiency with Microsoft Office and analytics tools.
Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Microsoft Access, Microsoft Visio, Microsoft Project, Tableau, Microsoft Power BI, Arena, NetSuite
10x GenomicsNASDAQ: TXG: Develops platforms for high-resolution single-cell and spatial biological analysis.
7+ YOEBachelor's or Master's in a relevant science/engineering field, 7 years supplier quality engineering in life sciences, experience with supplier audits, CAPA/SCARs, GD&T (ASME Y14.5), and ISO 9001/ISO 13485/FDA/GMP.
GD&T (ASME Y14.5 1994, 2009, & 2018), ISO 9001, ISO 13485, FDA/GMP, CAPA, SCARs
OutSystems: AI-powered low-code platform for building enterprise applications.
5+ YOE5+ years in quality engineering or software development; expertise with AI toolchain (Claude Code, Cursor, Gemini, GPT-4); SDLC and CI/CD leadership; proficiency in C#, Python or JavaScript and testing frameworks like Playwright or PyTest.
Claude Code, Cursor, Gemini, GPT-4, C#, Python, JavaScript, Playwright, PyTest
Foundry Robotics: An AI-native robotics manufacturer building advanced assembly and production systems.
7+ YOE7+ years quality engineering in regulated manufacturing; experience with AS9100D/ISO 9001:2015, QMS implementation and third-party certification, FMEA, control plans, process capability, GD&T, and root cause analysis.
AS9100D, ISO 9001:2015, FMEA, GD&T, APQP, PPAP, IPC workmanship standards
StrykerNYSE: SYK: Manufactures medical devices and equipment for healthcare providers.
6+ YOEBachelor's in science/engineering, 6+ years quality/R&D medical device experience, strong knowledge of ISO 13485, GMP/GDP, CAPA, risk management, complaint investigations, and regulatory interactions.
SanminaNASDAQ: SANM: Designs and manufactures complex electronics and mechanical systems.
4+ YOEBS in Engineering or equivalent experience; 4+ years quality engineering experience; expertise in GD&T, CMM, SolidWorks; knowledge of ISO/API Q1/AS9100, Lean, Six Sigma, CAPA, supplier audits, and statistical methods.
SolidWorks, CMM, GD&T, Microsoft Word, Microsoft Excel, Oracle, Lean, Six Sigma
Tempus AINASDAQ: TEM: Builds a data platform for AI-powered precision medicine diagnostics.
5+ YOEFive+ years in FDA-regulated domains; three+ years CSV; knowledge of design controls, ISO 13485, and related standards; strong QA and validation experience; ability to mentor others.
Senior Quality Engineer, Medical Device External Quality
Pleasanton or Lake County
$85k-$162k/yrOnsiteFull Time
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
6+ YOE6+ years quality engineering in FDA regulated medical device manufacturing; proficiency with mechanical drawings and GD&T; knowledge of QSR and ISO 13485; bachelor’s in engineering preferred; medical device auditor certification preferred.
Swagelok Northern California: Provides industrial fluid system components and custom assembly services.
5+ YOEBachelor's in engineering or quality, 5+ years manufacturing quality experience (2 years with Master's), experience with audits, root cause analysis, supplier quality, and data-driven continuous improvement.
PenumbraNYSE: PEN: Designs and manufactures medical devices for vascular conditions.
5+ YOEBachelor's in engineering, 5+ years quality/manufacturing engineering in medical devices, knowledge of FDA QSR and ISO 13485, strong data analysis and problem-solving, experience with pFMEA, NCR/MRB/CAPA processes.
5 Why, Fishbone Diagram, Design of Experiments (DOE), regression analysis, pFMEA, Measurement System Analysis (MSA), FDA QSR, ISO 13485, NCR, MRB, CAPA
AppleNASDAQ: AAPL: Designs and sells consumer electronics, software, and online services.
Hands-on quality engineer for backend pricing systems with strong technical depth, test strategy, and scalable automation to ensure reliability across services and regions.
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.
AMDNASDAQ: AMD: Designs and manufactures computer processors and graphics technology.
Experienced quality engineer with semiconductor or related industry background; skilled in customer engagements, root-cause analysis, structured quality methods (8D, RCA, FMEA, Six Sigma); BS in engineering preferred.
8D, RCA, FMEA, Six Sigma, x86 processors, GPUs, FPGAs