21 staff quality engineer jobs at 15 companies in Fallbrook, CA
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Staff Quality Engineer
Irvine, California, United States
$125k-$155k/yrOnsiteFull Time
Terran OrbitalNYSE: LMT: Manufactures modular spacecraft for aerospace and defense missions.
8+ YOEBachelor's in engineering, 8+ years in quality in high-reliability manufacturing (5+ years electronics), knowledge of IPC/MIL-STD/NASA guidelines, AIAG core tools (SPC, PFMEA, PPAP, APQP, MSA, QSA), root-cause analysis, and eligibility for DoD clearance; excellent visual acuity and color discrimination.
AIAG Core Tools, IPC, MIL-STD, NASA craft acceptability guidelines, SPC, PFMEA, PPAP, APQP, MSA, QSA, ISO 9001, AS9100
DexcomNASDAQ: DXCM: Develops continuous glucose monitoring systems for diabetes management.
13+ YOEExtensive medical device quality experience with FDA 21 CFR 820 and ISO 13485, audit readiness, leading investigations, data analysis (Excel,JMP), and cross-functional quality solutions; typically 13+ years experience.
Laguna Niguel or Orange County or United States or Costa Rica
$110k-$184k/yrOnsiteFull Time
Confluent Medical Technologies: Manufacturing complex components and implants for medical device companies.
5+ YOEBS/MS in engineering with 4–5+ years quality experience in medical device product development; strong knowledge of FDA, ISO 13485, EU MDR, ISO 14971; advanced statistical analysis using Minitab; competent in Microsoft Office.
DexcomNasdaq: DXCM: Manufacturer of continuous glucose monitoring systems for diabetes management.
13+ YOEExpertise with FDA 21 CFR 820 and ISO 13485, quality/compliance leadership in medical device environments, data analysis (Excel,JMP), audit readiness, and 13+ years technical experience (or equivalent advanced degree experience).
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
5+ YOEBachelor's in Engineering or Life Sciences, 5+ years quality engineering in IVD/medical device, design control, risk management (ISO 14971), V&V, regulatory knowledge (FDA, ISO, IVDR, China).
General Atomics Aeronautical Systems: A developer and manufacturer of remotely piloted aircraft and advanced surveillance systems.
6+ YOEBachelor's or master's in engineering (or equivalent experience), 4–6+ years related experience, strong inspection and analytical skills, ability to produce technical reports and lead staff, able to present technical material.
iRhythm TechnologiesNASDAQ: IRTC: Provides wearable heart monitors and AI-driven cardiac data analytics.
12+ YOE12+ years experience (or 8+ years with master’s) in computer science/engineering; expertise in FDA CSA, ISO 13485, 21 CFR Part 11; strong QA/GxP tooling and DevOps knowledge.
General Atomics Aeronautical Systems: Designs and manufactures unmanned aircraft and radar systems.
4+ YOEBachelor's or master's in engineering, 4–6+ years related experience, strong inspection and analytical skills, familiarity with GD&T/ASME Y14.5, ability to lead staff and obtain DoD security clearance.
Anduril Industries: Defense technology building autonomous military hardware and software.
15+ YOE15+ years building automated verification and CI/CD systems, HITL/SITL automation, Python scripting, container and Terraform experience, strong quality and reliability engineering background.
MaxLinearNASDAQ: MXL: Provides radio-frequency and mixed-signal semiconductor solutions for communications.
2+ YOEExperience delivering SOC products, knowledge of CMOS process and packaging, ATE experience, data-analysis tool proficiency, BS/MS/PhD in EE or related with relevant years, strong cross-functional and quality focus.
ATE, Verigy, Teradyne, Excel VBA, JMP, Galaxy, Data Conductor, PDF Exensio, Optimalplus
Werfen: Develops specialized diagnostic systems and reagents for clinical laboratories.
10+ YOEBS/BA in CS or related,10+ years embedded software development,expertise in C/C++ and Qt,experience with real-time/embedded Linux or RTOS,knowledge of FDA/IVDR quality processes and CI/CD tooling.
StrykerNYSE: SYK: Manufactures medical devices and equipment for healthcare providers.
4+ YOEBachelor's in Mechanical/Biomedical engineering, 4+ years relevant engineering experience, medical device/regulatory experience preferred, SolidWorks and GD&T experience, proficiency with Microsoft Office, design verification/validation and quality system knowledge.
SolidWorks, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, MS Project, Minitab
Yum! BrandsNYSE: YUM: Global operator of quick-service restaurant brands.
7+ YOEBS in IT,7+ years QA experience,5+ years with AWS/Snowflake,3+ years test script development,knowledge of dbt or Great Expectations,ability to lead validation and mentor junior staff.
AWS, JSON, XML, Snowflake, dbt, Great Expectations, CI/CD