30 capa jobs at 20 companies in Littleton, CO
3w
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Validation Engineer
Frederick or Boulder
$82k-$129k/yr OnsiteFull Time
1+ YOEBachelor's in engineering or life sciences,1+ years relevant experience,knowledge of cGMP/FDA/ICH regulations,validation experience (IQ/OQ/PQ/SAT),CAPA and change control experience.
URS, Software Acceptance Testing (SAT), IQ, OQ, PQ, GAMP, 21 CFR, ICH, Eudralex Volume 4 Annex 15, CAPA, spreadsheets
6d
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Supplier Quality Engineer
Boulder, Colorado, United States
$85k-$105k/yr OnsiteFull Time
1+ YOEBachelor's degree or equivalent experience and 1–3 years in supplier quality, quality engineering, manufacturing quality, or a related technical role; knowledge of quality systems, risk assessment, root cause analysis, and CAPA.
Quality Management System (QMS), Enterprise Resource Planning (ERP), SAP, Microsoft Power BI, Minitab, SQL, FMEA, SPC, MSA, 5 Why, Ishikawa analysis, CAPA, First Article Inspection (FAI), Supplier Corrective Action Request (SCAR), ISO 9001
1mo
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Quality Engineer
Arvada, Colorado, United States
$85k-$95k/yr OnsiteFull Time
1+ YOE1-3 years in Class II/III medical device or regulatory industry; knowledge of FDA and ISO 13485; CAPA and complaint investigation experience; risk management and data analysis skills; Bachelor's in technical/scientific discipline required.
ISO 13485, MDSAP, CAPA
3mo
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Quality Assurance Technician
Denver or United States
$21-$25/hr OnsiteAll Commitments Available
Supports QA Manager in SQF, GMP, and food safety; conducts inspections, monitors CCPs, supervises sanitation, and supports CAPA and continuous improvement.
MS Office
3mo
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Quality Engineer I - Compliance (10339)
Englewood, Colorado, United States
$60k-$80k/yr OnsiteFull Time
1+ YOEBachelor’s degree and 1+ year related experience; familiarity with 21 CFR 820/ISO13485; knowledge of QMS, CAPA; MS Office and Adobe.
MS Office, Adobe
1mo
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Associate Director, Quality Assurance GCP
United States or Waltham or Boulder
$180k-$205k/yr RemoteFull Time
8+ YOEProvide GCP QA leadership, lead audits and inspection readiness, manage CAPAs and vendor oversight; requires 8+ years GCP QA experience and a scientific bachelor's degree.
1mo
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Quality Manager
Lafayette, Colorado, United States
$105k-$130k/yr OnsiteFull Time
Probi: Researches and manufactures clinically proven probiotic health solutions.
3+ YOELead QA/QC and microbiology lab, implement QMS, manage audits/inspections, CAPA, deviations, change control, and mentor quality staff; 3+ years cGMP/GLP and microbiology experience required.
4w
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Quality and Risk Lead
Denver, Colorado, United States
$85k-$95k/yr RemoteFull Time
2+ YOEBachelor's or commensurate experience, minimum 2 years clinical research quality support, GCP knowledge, root cause analysis and CAPA, strong communication, ability to travel and drive, daily computer use.
Office365
1mo
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Manager - Manufacturing Specifications (Aurora, CO, US, 80019)
Aurora, Colorado, United States
$150k-$187k/yr OnsiteFull Time
5+ YOEBachelor's degree in engineering, supply chain, business or related; experience with PLM/ERP and specification/master data management; proven leadership in manufacturing or regulated environments; data governance, RCA/CAPA, project management.
PLM, ERP, BOM, RCA/CAPA
2w
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Design Quality Engineer II
Lafayette, Colorado, United States
$79k-$119k/yr OnsiteFull Time
2+ YOEBachelor's in engineering or related plus 2 years relevant quality/regulated industry experience; familiarity with QMS, ISO 13485, ISO 14971, design controls, risk management, V&V, CAPA, and cross-functional communication.
Minitab
1mo
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Director, Quality Assurance
Louisville or Centennial
$202k-$277k/yr OnsiteFull Time
Bachelor's or equivalent, proven experience managing large teams and QA programs in regulated industries, deep knowledge of FDA/ISO/GxP, experience with product release, CAPA, change control, validation, audits, risk management, and strong communication.
eQMS
1mo
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QMS Specialist
Westminster, Colorado, United States
OnsiteFull Time
3+ YOEImplement and maintain CAPA, lead HHE and Field Action programs, support audits and document control, monitor regulatory changes; Bachelor's in technical discipline or quality certification (CQE/CQA) and 3+ years medical device/pharma experience required.
Microsoft PowerPoint, Microsoft Excel
1mo
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Sr. Manufacturing/Process Engineer
Westminster, Colorado, United States
$115k-$125k/yr OnsiteFull Time
10+ YOEBS in engineering required; 10+ years medical device manufacturing experience in FDA-regulated environment; expertise in process validation (IQ/OQ/PQ), DOE/SPC/MSA, PFMEA, CAPA, ISO 13485 and 21 CFR Part 820; cleanroom experience.
1mo
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Senior Sustaining Engineer
Niwot, Colorado, United States
$95k-$140k/yr HybridFull Time
6+ YOE6+ years supporting fielded products or equivalent experience; diagnosing hardware/software/system issues; proficiency with Python and PowerShell; experience with Modbus, Ethernet/IP, OPC UA; structured problem-solving (8D/A3/RCA); ability to drive CAPA and collaborate across R&D, quality, and service.
Python, PowerShell, Modbus, Ethernet/IP, OPC UA
2mo
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Sr. Mechanical Engineer -
Lafayette, Colorado, United States
$106k-$160k/yr HybridFull Time
4+ YOEBachelor's degree in Mechanical Engineering (or higher), 4+ years medical device or regulated-industry experience (alternatives: MS +2 yrs, PhD +0), knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, design controls, DHF, CAD (SolidWorks/Creo/NX), NPI, RCA/CAPA.
SolidWorks, Creo, NX, FEA
1w
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Product Engineer
Denver, Colorado, United States
$86k-$92k/yr OnsiteFull Time
0+ YOEBachelor's degree in an engineering discipline, 0–2 years of engineering experience, SolidWorks or 3D CAD experience, and strong analytical, problem-solving, communication, organizational, and project management skills.
SolidWorks, 3D CAD, Lean, Six Sigma, CAPA, ISO
23h
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Quality Assurance Supervisor
Aurora, Colorado, United States
$58k-$90k/yr OnsiteFull Time
Bachelor's degree preferred; QA knowledge, people management, computer applications, data analysis, communication, training, facilitation, and self-management skills required.
CAPA, Gemba
2mo
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Plant Maintenance Manager (Food Manufacturing)
Aurora, Colorado, United States
$140k-$160k/yr OnsiteFull Time
5+ YOE7+ MgmtBachelor's in Engineering or related field; 5+ years CMMS; 7+ years manufacturing leadership; TPM/AM/PM experience; knowledge of USDA/SQF/BRC/GMP/HACCP; CI experience; ability to influence plant leadership.
CMMS, RAMS, GMP, CAPA, HACCP
2mo
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Plant Maintenance Manager (Food Manufacturing)
Aurora, Colorado, United States
$140k-$160k/yr OnsiteFull Time
5+ YOE7+ MgmtBachelor's in Engineering or related field; 5+ yrs CMMS; 7+ yrs maintenance leadership; TPM/AM/PM experience; knowledge of USDA/SQF/BRC/GMP/HACCP; continuous improvement; CMRP certification preferred.
CMMS, RAMS, CAPA, GMP, HACCP, Predictive Maintenance
1w
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Filling Team Leader- 3rd Shift
Englewood, Colorado, United States
$27-$31/yr OnsiteFull Time
Leadership and aseptic processing experience preferred; high school diploma or associate degree, cGMP knowledge, Microsoft 365 proficiency, English communication skills, and ability to lift 50 lbs. required.
Microsoft Office, Microsoft 365, Microsoft Outlook, Microsoft Excel, FSA, HSA, CAPA, cGMP, FDA