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
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
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
2mo
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Production Engineer
Santa Ana, California, United States
$91k-$119k/yr OnsiteFull Time
5+ YOEBachelor in Chemical Engineering or similar; 5-7 years in manufacturing/process engineering in a cGMP environment; GMP knowledge; bioprocessing equipment experience; strong communication; CAPA, change control; Lean/Six Sigma; English proficiency.
cGMP, CAPA, SOPs, BOM management, EBR management, QMS, Lean Manufacturing, Six Sigma
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
1mo
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Senior Engineer, Supplier Quality Assurance
Rancho Cucamonga, California, United States
$98k-$113k/yr OnsiteFull Time
8+ YOEBachelor's in engineering/science required; 8+ years experience; certified auditor required; knowledge of ISO 13485, 21 CFR Part 820, GMPs, PPAP, CAPA, Gage R&R, DMAIC/Six Sigma and quality engineering/statistics.
ISO 13485, 21 CFR Part 820, GMPs, DMAIC, Six Sigma, PPAP, CAPA, Gage R&R, Process Audit, Equipment Validation
1mo
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Quality Program Manager
Santa Ana, California, United States
$110k-$160k/yr OnsiteFull Time
7+ YOE7+ years in quality management or quality-focused program management; hands-on with root cause analysis, CAPA, FMEA, SPC, Lean/Six Sigma; strong data analysis and dashboarding skills; ability to lead cross-functional programs; bachelor's degree in engineering/operations preferred; up to 20% travel and valid passport required.
Lean, Six Sigma, Kaizen, FMEA, CAPA, statistical process control, business intelligence (BI) tools
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
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.
3mo
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Quality Engineer
Huntington Beach, California, United States
$95k-$180k/yr OnsiteFull Time
3+ YOEBachelor's degree in a STEM field; 3–5+ years in quality, RCA/CAPA, PFMEA, QC docs, and QMS; ability to read engineering drawings.
QMS, PFMEA, Control Plans, SPC, Gage R&R, AS9100, ISO 9001
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
4w
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Sr. Manager, Design Assurance Engineering
Pomona or Brea
$152k-$185k/yr OnsiteFull Time
10+ YOE5+ MgmtBachelor's in Engineering, 10+ years in regulated industry, 5+ years leading teams; expertise in design controls, supplier quality, validation, CAPA, audits, and digital quality systems.
eQMS, eDHR, Lean, Six Sigma
3w
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Quality Systems Specialist
Carlsbad, California, United States
$36-$40/hr OnsiteFull Time
2+ YOE2+ years QA experience in cGMP environment preferred; Bachelor’s degree or equivalent experience; experience with MasterControl, batch record review, CAPA, deviations, and ISO 13485 compliance.
MasterControl, LIMS, ERP
1d
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Complaint Quality Engineer II - PMS
Irvine, California, United States
$87k-$123k/yr OnsiteFull Time
2+ YOEBachelor's in engineering/science with 2 years quality engineering experience (or Master's with internship/none); experience in complaint/CAPA investigations, root cause analysis, risk assessment, lab testing, and documentation.
calipers, micrometers, pressure gages, leak testing
1w
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Quality Assurance Specialist
Irvine, California, United States
$71k-$85k/yr OnsiteFull Time
5+ YOE5+ years QA experience in GMP manufacturing with batch record review/approval, deviation/CAPA management, knowledge of CFR/ICH/GMP, attention to detail, and strong written/verbal communication.
1mo
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Quality Engineer II
Irvine, California, United States
$90k-$100k/yr OnsiteFull Time
3+ YOEBachelor's in engineering/science required, 3+ years engineering experience in medical device/pharma, knowledge of QMS (FDA QMSR, ISO 13485), CAPA/NCMR experience, data analysis and documentation skills.
Microsoft Project, Word, Microsoft Excel, PowerPoint, Windows, Visio
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