3d
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Principal Quality Systems Specialist - CAPA
Northridge or Minneapolis or San Diego
$109k-$185k/yr HybridFull Time
5+ YOEBachelor's degree with 7+ years (or advanced degree with 5+ years) in medical device/pharma quality, 3+ years CAPA experience, audit support, regulatory knowledge, and CAPA system experience.
Trackwise
1mo
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CAPA Engineer
Rancho Santa Margarita, California, United States
$72k-$78k/yr OnsiteFull Time
Bachelor's in Engineering/STEM required (or related experience). Strong problem solving, root cause analysis, statistics, and communication. Working knowledge of Microsoft Office; ETQ Reliance experience preferred.
Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft Outlook, ETQ Reliance
1mo
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Quality Engineer CAPA & CI
Poway, California, United States
$89k-$156k/yr OnsiteFull Time
4+ YOEBachelor's or master's in engineering with 4–6+ years engineering experience, ability to obtain DoD Secret clearance, leadership, root cause analysis, PFMEA, SAP experience, strong communication and project management skills.
PFMEA, AS9100, SAP
2mo
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Quality Assurance Manager
Irvine, California, United States
$125k-$160k/yr HybridFull Time
10+ YOE2+ MgmtLead and maintain enterprise QMS, ensure ISO compliance, audits, CAPA, and cross-functional quality leadership.
QMS, CAPA, Auditing
2mo
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Senior Associate, QA Compliance
San Diego, California, United States
$99k-$120k/yr OnsiteFull Time
5+ YOE5+ years in FDA-regulated CGMP; bachelor’s degree; experience with deviations, CAPA, change control, audits.
Quality Management System, CAPA, Deviation tracking, Change control, Document control
2w
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Product Assurance Engineer
San Diego, California, United States
$90k-$120k/yr OnsiteFull Time
5+ YOEMaintain AS9100 QMS, perform inspections and supplier audits, manage NCR/CAPA and root-cause analysis, familiarity with MIL-STD/NASA/MDA, ability to obtain U.S. security clearances.
AS9100, ISO 9001, MIL-STD, 8D, CAPA
2mo
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Quality Engineer I-1503
Tijuana, Baja California, Mexico
OnsiteFull Time
Industrial/Quality engineering; experience with quality systems ISO 9001 and IATF 16949; internal audits; quality tools (8D, CAPA, FMEA, SPC); English (intermediate/advanced); MS Office.
Quality management systems (ISO 9001, IATF 16949), 8D, CAPA, FMEA, SPC, Microsoft Office
1mo
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Copy Of Senior R&D Engineer - Medical Device #8994
Marlborough or Irvine
OnsiteFull Time, Contract
5+ YOEBachelor's in engineering (or equivalent experience), 5+ years R&D experience in medical device electromechanical products, strong quality and regulatory knowledge (FDA/ISO), proficiency with quality tools (SPC, DOE, FMEA, CAPA).
SPC, DOE, ANOVA, GR&R, FMEA, CAPA, IQ, OQ, PQ
3w
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Quality Assurance Engineer
El Cajon, California, United States
$29-$35/hr OnsiteFull Time
3+ YOE3+ years quality engineering in electronics/aerospace, Bachelor's in engineering or equivalent, AS9100/ISO9001 knowledge, FAI/AS9102, GD&T, SPC/Cpk, root-cause/CAPA experience, strong communication, U.S. Person (ITAR).
AS9100, ISO 9001, 8D, 5-Why, fishbone analysis, CAPA, AS9102, GD&T (ASME Y14.5), SPC, Cpk, Gage R&R, AS9101, FMEA, AS5553, J-STD-001, IPC-A-610, MIL-STD-202, MIL-STD-883, DPAS
1mo
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Quality Engineer III (SSO Division – Location: Irvine, CA)
Irvine, California, United States
$100k-$167k/yr OnsiteFull Time
5+ YOE5+ years quality experience with a Bachelor’s (or 3+ years with advanced degree). Strong QMS, audit, MRB/CAPA, supplier quality, and problem-solving skills; ISO/AS9100 knowledge and scheme auditor preferred; US citizenship required.
A3, 8D, DMAIC, RCA, CAPA, PFMEA, Control Plan, SPC, MSA, PPAP, FAI, PQDR, PHConnect, Minitab, GD&T
2mo
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Sustaining Engineer
Irvine, California, United States
$130k/yr OnsiteFull Time
2+ YOESustaining engineer to maintain and improve released products, manage ECOs, CAPAs, RCA, and cross-functional support.
SolidWorks, Inventor, PLM, Excel, Word
3w
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Staff QA Engineer
San Diego, California, United States
$111k-$185k/yr OnsiteFull Time
8+ YOEExpertise in QMS, nonconforming events, CAPA, audits, dashboard development, statistical analysis, and medical device quality/compliance.
Power BI, Tableau, Oracle, Camstar, IQVIA, 1Factory, EtQ Reliance, SQL Servers, Google Big Query, Minitab, Jump
1mo
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QA Specialist
Costa Mesa, California, United States
$65k-$75k/yr OnsiteFull Time
2+ YOEReview batch records for FDA/EMA compliance, identify deviations, support CAPA, ensure ALCOA+ data integrity in a CDMO environment.
eQMS, Microsoft Office
2w
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Quality Investigator
Irvine, California, United States
$71k-$89k/yr OnsiteFull Time
2+ YOEBachelor's degree, 2+ years in quality/manufacturing/regulated environment, knowledge of GMP and CAPA, strong analytical and technical writing skills.
6d
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Quality Manager
Costa Mesa, California, United States
$100k-$135k/yr OnsiteFull Time
5+ YOE2+ Mgmt5+ years QA in manufacturing, 2+ years leading teams, experience with audits/inspections, risk analysis and CAPA, strong analytical and technical writing skills.
2mo
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Software Quality Engineer II
Irvine, California, United States
$75k-$100k/yr OnsiteFull Time
3+ YOEBachelor’s in technical field; 3+ years in Quality/Software Quality; SDLC knowledge; regulatory experience; CAPA and complaint handling; strong communication; MS Office proficiency.
SDLC, quality documentation systems, Microsoft Office
2d
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QC Analyst
Carlsbad, California, United States
$70k-$130k/yr OnsiteFull Time
Bachelor's in chemistry/biochemistry/microbiology, experience in FDA-regulated pharmaceutical analytical testing, knowledge of GMP and data integrity, HPLC/UPLC experience, deviation/CAPA experience.
High-Performance Liquid Chromatography, Ultra Performance Liquid Chromatography, Empower
3d
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Supplier Quality Engineer 1
Irvine, California, United States
OnsiteFull Time
0+ YOEMaintain and process nonconforming materials, perform root cause analysis and CAPA/SCAR, inspect product, analyze statistical data, and support MRB and supplier quality activities.
Minitab, Microsoft Excel, Microsoft Access, M2M, CMM, vision systems, calipers, micrometers, gages, indicators
2mo
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MSAT Associate 2
San Diego, California, United States
$73k-$88k/yr OnsiteFull Time
2+ YOEBachelor’s degree and 2+ years of hands-on cGMP biologics manufacturing; experience with adherent cell culture; technical writing; data analysis; deviations/CAPAs; GMP, QA collaboration.
1mo
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QA Associate III
San Diego, California, United States
$30-$33/hr OnsiteFull Time
3+ YOE3+ years GMP QA experience, HS required (bachelor's in Life Sciences preferred). Knowledge of cGMP, documentation review, investigations, audits, CAPA, and Microsoft Office required.
Microsoft Office, ERP
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