32 quality systems specialist jobs at 27 companies in Irvine, CA
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Sr. Specialist, Quality Systems
Tustin, California, United States
$43-$56/hr OnsiteFull Time
4+ YOEBachelor's degree, 4–5 years of biopharmaceutical experience, cGMP knowledge, quality systems software experience, technical writing, deviation records, and independent problem-solving skills.
quality management systems, electronic document management systems
1mo
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Principal Quality Systems Specialist
Northridge or California or Seattle or Washington or Boston or New York City or Los Angeles County or United States
$121k-$205k/yr OnsiteFull Time
5+ YOEBaccalaureate degree with 7+ years (or advanced degree with 5+ years) in quality systems; experience with QMS, Change Management, CAPA, audits, and Microsoft Office; strong communication and prioritization skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Agile, Trackwise, Microsoft Teams, Microsoft Project, Power BI
3w
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Quality Systems Specialist
Aliso Viejo, California, United States
$85k-$100k/yr OnsiteFull Time
2+ YOEManage equipment lifecycle, schedule calibrations/PMs, track events and maintain equipment records; knowledge of ISO 13485 and 21 CFR; bachelor\u0002s degree and 2 years relevant experience.
xTrak, Microsoft Word, Microsoft Excel, Smartsheet, Power BI
1d
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Quality Systems Specialist
Carlsbad, California, United States
$36-$40/hr OnsiteFull Time
4+ YOERequires 4+ years in pharmaceutical or biotech manufacturing focused on GMP investigations, strong root-cause analysis and technical writing skills, FDA and ICH knowledge, and excellent communication. Bachelor's degree strongly preferred.
MasterControl, NetSuite, FDA, cGMP, ISO, ICH, CAPA
3w
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Senior Specialist, Quality Systems
Carlsbad, California, United States
$102k-$131k/yr OnsiteFull Time
3+ YOE3-5 years QA/QC experience in regulated medical device environment; expert knowledge of FDA QSR, ISO 13485/14971 and international standards; experience with electronic QMS, LMS and PLM systems and internal auditing.
Agile, Reliance EtQ, Master Control, Oracle, Pilgrim, LMS, PLM, Microsoft Office
1w
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P/T Quality Systems Complaints Specialist
Irvine, California, United States
$30/hr OnsitePart Time
1+ YOERequires 1+ year in medical device quality or operations, MS Office proficiency, familiarity with ISO 13485 and 21 CFR 820, electronic quality and document systems, root cause analysis, communication, and organizational skills.
Microsoft Word, Microsoft Excel, Microsoft Outlook, QCBD, EtQ, Oracle Agile, Documentum, PLM
3w
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Quality Specialist II, Quality Systems
Carlsbad, California, United States
$66k-$88k/yr OnsiteFull Time
2+ YOEBachelor's in a scientific field,2+ years QA/QC experience in regulated industry (RUO preferred),knowledge of QMS,change management,CAPA,root-cause analysis,data analysis,organizational and communication skills.
Microsoft Office
2mo
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Quality Specialist, Intelligence Systems (Second Shift)
Santa Ana, California, United States
$41-$55/hr OnsiteFull Time
3+ YOE3+ years metrology/quality inspection experience, associate degree or equivalent, proficiency with ERP/MES and inspection tools, GD&T knowledge, ability to maintain active U.S. Secret clearance.
Lattice OS, ERP, MES, CMM, Faro arm, CAD, calipers, micrometers, OMM, x-ray inspection
3mo
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Warehouse Quality Specialist
Irvine, California, United States
$87k-$119k/yr OnsiteFull Time
3+ YOEBachelor’s degree in a relevant science or engineering field; 3–5 years of regulated quality systems experience; 2 years with ERP systems; QMS, audit, leadership, and continuous improvement skills.
Quality Management System (QMS), Enterprise Resource Planning (ERP), SAP, Oracle, Microsoft Word, Microsoft Excel
3mo
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Sr. Quality Assurance Specialist
La Verne, California, United States
$124k-$160k/yr OnsiteFull Time
4+ YOEBachelor’s or Master’s or PhD/PharmD with required experience; QA systems, GMP, and regulatory interactions; strong communication.
GMP, CAPA, Deviation, Change Management, Batch Record Review
2mo
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Quality Specialist II (USA|Irvine, CA, US, 92614)
Irvine, California, United States
$96k-$118k/yr OnsiteFull Time
6+ YOEBachelor's degree or equivalent, 6+ years in a regulated industry, strong quality systems and data integrity knowledge, ability to review documentation and support investigations, excellent problem-solving and communication skills.
1mo
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(Senior) Quality Specialist for Distributed Systems (Riverside, CA, US)
Riverside, California, United States
OnsiteFull Time
Experience with distributed systems, system administration on Linux, proficiency in two of Java/C++/Python, BS/MS in CS or Electrical Engineering, strong architecture and cloud platform knowledge.
Linux, Java, C++, Python, Hadoop, HDFS, Spark
1mo
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Quality Assurance Specialist
Los Angeles, California, United States
$80k-$93k/yr OnsiteFull Time
4+ YOE4+ years in food quality assurance or food safety, experience with specification management, supplier qualification, audits (SQF/BRC/FSSC 22000), HACCP knowledge, COA/allergen/label review, and familiarity with FoodLogiQ or similar systems.
FoodLogiQ
2w
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Specialist - Quality System and Customer Service (57559)
City of Industry, California, United States
$75k-$85k/yr OnsiteFull Time
2+ YOEExperience in nutraceutical or pharmaceutical manufacturing, GMP knowledge, internal audits, CAPA, SOPs, HACCP, customer quality support, and quality metrics reporting; HS+5yrs or College+2yrs acceptable.
2w
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Document Control Specialist
Huntington Beach, California, United States
$27-$32/hr OnsiteFull Time
1+ YOE1–5 years quality/document control experience, knowledge of ISO 9001:2015, experience with document control systems, strong communication, attention to detail, and proficiency with Microsoft Windows/MAC and Microsoft Office.
Microsoft Windows, MAC, Microsoft Office
3w
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Document Control Specialist I
Irvine, California, United States
$59k-$74k/yr OnsiteFull Time
Provide document and change control support, maintain controlled records, support audits, train PLM users; familiarity with document control systems and quality regulations required.
Product Lifecycle Management (PLM), Microsoft Word, Microsoft Excel, Microsoft Outlook
6d
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Test Specialist (Composites)
Hawthorne or Cape Canaveral or Vandenberg
$30-$48/hr OnsiteFull Time
1+ YOEHigh school diploma plus engineering/STEM bachelor's degree or 2+ years manufacturing experience; 1+ year manufacturing test experience. Requires hands-on systems testing, hazardous-system work, travel, and Air Force background-check eligibility.
CAD
1mo
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Senior Specialist, Regulatory Affairs (THV)
Irvine, California, United States
$95k/yr OnsiteFull Time
3+ YOE3–5 years medical device regulatory affairs experience, bachelor’s in a scientific discipline, knowledge of global medical device regulations and quality systems, strong writing and communication skills, and ability to manage submissions and adverse event reporting.
Microsoft Office Suite
1mo
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Quality and Environmental Health and Safety (EHS) Specialist
Rancho Cucamonga, California, United States
$83k-$103k/yr OnsiteFull Time
3+ YOEBachelor's degree or 5 years equivalent; 3+ years manufacturing experience; knowledge of OSHA and ISO; proficiency with Microsoft 365 and QMS/EHS systems; strong communication and CI/Lean familiarity.
Microsoft 365, Quality Management System (QMS), EHS systems
2d
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Experienced Production Operations Specialist (Electro-Mechanical) Second Shift – Millennium Space Systems
El Segundo, California, United States
$97k-$131k/yr OnsiteFull Time
3+ YOE1+ Mgmt3+ years manufacturing experience, specialized equipment operation, 1+ year team leadership, aerospace experience, U.S. citizenship, and eligibility for a Top Secret clearance. Bachelor's degree and data-analysis tools preferred.
Electrodynamic shakers, Thermal Vacuum Chambers, Thermal Cycling Chambers, Microsoft Excel, SQL, Power BI
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