204 iso jobs at 113 companies in San Diego, CA
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ISO Specialist
Tijuana, Baja California, Mexico
OnsiteFull Time
2+ YOEBachelor's degree in engineering, industrial management, or a related technical field; 2–3 years of manufacturing QMS experience; ISO 9001, auditing, corrective action, nonconformity, and document control experience.
Quality Management System (QMS), ISO 9001, 5 Whys, Fishbone Diagram, 8D, Pareto Analysis
1w
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ISO Specialist
Tijuana, Baja California, Mexico
OnsiteFull Time
2+ YOEBachelor's degree in engineering or a related technical field; 2–3 years in manufacturing QMS, ISO 9001, internal and external audits, corrective actions, nonconformities, document control, and cross-functional teams.
QMS, ISO 9001, 5 Whys, Fishbone Diagram, 8D, Pareto Analysis
1mo
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Direct Materials Regulatory Filings Principal Expert
Oceanside or Mississauga
$115k-$213k/yr OnsiteFull Time
8+ YOEBS/MS/PhD in science, engineering, or management and 8+ years pharmaceutical/biopharmaceutical experience with regulatory filings and material specifications; expert knowledge of ICH, ISO, GMP, and operational excellence tools.
ICH, ISO, FMEA, Six Sigma, Lean Principles
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Manager, Quality Engineer
San Diego, California, United States
$120k-$145k/yr OnsiteFull Time
5+ YOEBachelor's in engineering,5+ years medical device/ISO or cGMP experience,catheter/device experience,complaint/CAPA and validation experience,statistical methods (Six Sigma,DOE),ASQ preferred.
Six Sigma, DOE, ASTM, ISO, ICH
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Quality Engineer
El Cajon, California, United States
$94k-$113k/yr OnsiteFull Time
3+ YOEBachelor's degree or equivalent education and experience, 3+ years in quality or manufacturing, Microsoft Office proficiency, and attention to detail. ISO, Six Sigma, AS9100, and statistical process control experience preferred.
Microsoft Office Word, Microsoft Excel, Six Sigma, ISO, AS9100
4w
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IT Security Compliance Analyst
Vista, California, United States
$63k-$98k/yr HybridFull Time
3+ YOE3+ years IT security/compliance or audit experience; knowledge of ITGCs, access management, SOX/PCI/NIST/CIS/ISO frameworks; Active Directory and ServiceNow familiarity; strong communication and organizational skills.
ServiceNow, Active Directory, Microsoft Outlook, Microsoft Word, Microsoft Excel, ITIL, NIST, CIS, SOX, PCI, ISO
6d
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Inventory Control Associate I
San Diego, California, United States
$20-$25/hr OnsiteFull Time
1+ YOERequires 1–2 years of inventory control experience and a high school diploma or GED. Preferred experience includes ERP/MRP, life sciences, quality systems, ISO environments, and Lean Six Sigma.
Enterprise Resource Planning system, Materials Requirements Planning (MRP), ERP, ISO, Lean Six Sigma, JIT, Kanban, 5’s, ISO13485, MDSAP, FDA, Bswift
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Production Manager - OS
Oceanside, California, United States
$95k-$115k/yr OnsiteFull Time
5+ YOE3+ MgmtAssociate's or bachelor's degree in business administration, operations management, or related field; 5–7 years manufacturing experience; 3+ years supervisory experience; Lean, Six Sigma, DMAIC, OSHA, ISO, KPI, and ERP knowledge.
Lean, Six Sigma, DMAIC, Kaizen, Just-in-Time (JIT), MRP, ERP, Microsoft Office 365, IFS ERP, OSHA, ISO, OEE, FPY, OTD
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Manager, QA Method Validation
Carlsbad, California, United States
$114k-$212k/yr OnsiteFull Time
8+ YOEBachelor's in a related field, 8+ years in clinical/GMP labs, 3+ years supporting IVD development, regulatory knowledge (GxP, Part 11, ICH, ISO, CLIA/CAP, IVDR, QSR), molecular biology familiarity, statistical understanding, strong communication.
GxP, Part 11, ICH, ISO, CLIA/CAP, IVDR, QSR
2d
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Lab Supervisor
San Diego, California, United States
$85k/yr OnsiteFull Time
Knowledge of ISO 9001 and ISO/IEC 17025 requirements, electronic test equipment repair and calibration, and MET/TEAM or MUDCATS software; bachelor's degree preferred.
MET/TEAM, MUDCATS
2mo
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Senior Supplier Quality Engineer
Tijuana, Baja California, Mexico
OnsiteFull Time
5+ YOE5+ years supplier quality experience in medical devices; knowledge of 21 CFR 820, ISO 13485, ISO 14971; audits; English proficiency; engineering background.
PPAP, MSA, Gage R&R, GD&T, Six Sigma, Statistical Analysis, Audit
1d
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Mfg/Ops Quality Engineer 1
San Diego, California, United States
$63k-$94k/yr OnsiteFull Time
0+ YOEBachelor's degree required; 0–2 years in quality assurance in a regulated environment. Requires knowledge of 21 CFR 820, ISO 13485, ISO 14971, IVDD, and quality controls; SAP preferred.
ERP, SAP, 21 CFR 820, ISO 13485, ISO 14971, IVDD
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Senior Design Quality Engineer - Bolt Integration
Carlsbad or Maple Grove or Arden Hills
$89k-$170k/yr HybridFull Time
5+ YOEBachelor's degree in engineering or science,5+ years in design assurance or medical device regulated industry,knowledge of 21 CFR 820, ISO 13485, ISO 14971,strong communication and quality tools experience.
Hazard Analysis, Fault Tree, FMEAs, IEC 62304
1mo
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Staff NPI Process Quality Engineer
San Diego, California, United States
$130k-$207k/yr OnsiteFull Time
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).
1mo
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Senior Design Quality Engineer - Medical Devices
Carlsbad or Chicago or Raleigh or Durham or Greensboro or Pittsboro
$100k-$140k/yr HybridFull Time
5+ YOEBachelor's degree,5+ years relevant experience,knowledge of FDA 21 CFR 820/ISO 13485/ISO 14971,cGMP,GxP; experience with electromechanical devices, audits, risk management, and verification/validation.
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Tooling Engineer
Tijuana, Baja California, Mexico
OnsiteFull Time
Supports plastic component and injection mold design, technical drawings, reverse engineering, engineering changes, supplier collaboration, tooling projects, cost reduction, quality, EHS, ISO 9001, and ISO 13485 compliance.
Engineering Change Orders (ECOs), ISO 9001, ISO 13485
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Quality Systems Engineer
San Diego, California, United States
$80k-$100k/yr OnsiteFull Time
3+ YOEBachelor's in engineering or related field, 3+ years quality systems experience in regulated manufacturing, knowledge of ISO 13485/AS9100/ISO 9001 and ITAR, audit and CAPA experience, strong communication and project skills.
eQMS
1d
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SubChapter Lead Regulatory Affairs - Lab Coagulation and Clinical Chemistry
Indianapolis or Branchburg or Santa Clara or Penzberg or Carlsbad or Rotkreuz or Pleasanton or Mannheim or Tucson or Motherwell
$111k-$259k/yr OnsiteFull Time
7+ YOEBachelor's or advanced science degree; 7+ years in diagnostics regulatory affairs; expertise in IVD, pharmaceutical or medical devices, global submissions, FDA, EU Notified Bodies, cGMP, QSR, ISO 13485 and ISO 27001.
US FDA, ISO 13485, ISO 27001, Agile
3w
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Sr Eng, Supplier Quality
Tijuana, Baja California, Mexico
OnsiteFull Time
3+ YOEDegree in engineering, 3+ years quality or supplier audit experience desired, knowledge of FDA CFR 820, ISO 13485 and ISO 9000, supplier audit and corrective action management, strong documentation and communication skills.
2mo
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Relocate to Australia: Deputy Lead - Nuclear Safety Management System Assurance
San Diego or Adelaide or Australia
HybridFull Time
10+ YOEDegree in relevant discipline preferred; 10+ years in nuclear/defence/safety-critical industries; experience implementing management systems, governance and assurance programmes; audit/compliance experience and familiarity with IAEA, WANO, INPO, ISO 9001 and ISO 19443.
IAEA, WANO, INPO, ISO 9001, ISO 19443
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