33 capa jobs at 22 companies in Lafayette, CO
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CAPA Specialist (11083)
Englewood, Colorado, United States
$60k-$75k/yr OnsiteFull Time
2+ YOE2+ years related experience (medical device preferred); CAPA management, QMS auditing, familiarity with 21 CFR 820 and ISO 13485; basic MS Office skills; strong problem-solving and collaboration skills.
Quality Management System (QMS), Microsoft Office
2w
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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
2d
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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
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ACS Quality Engineer - Workstation Products
Fort Collins, Colorado, United States
$83k-$120k/yr OnsiteFull Time
4+ YOEBachelor's or graduate degree in engineering or equivalent experience; typically 4+ years in quality assurance/reliability; skills in root cause analysis, data analysis, ISO 9000, CAPA, test automation, and project collaboration.
Agile Methodology, Corrective And Preventive Action (CAPA), ISO 9000 Series, Test Automation, Good Manufacturing Practices
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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
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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
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Manager Perioperative Patient Safety, QA & Regulatory UCH
Aurora, Colorado, United States
$48-$76/hr OnsiteFull Time
3+ YOEBSN required, CNOR/CAPA/CPAN certification, 3 years perioperative or related clinical experience, experience leading safety/quality programs and regulatory compliance.
3w
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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.
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QA Product Specialist
Boulder, Colorado, United States
$100k-$118k/yr OnsiteFull Time
5+ YOEBachelor's in science and 5 years pharmaceutical QA experience (or equivalent), strong cGMP/cGLP/FDA knowledge, validation and CAPA experience, audit support, technical review and quality leadership skills.
3w
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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
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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.
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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
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ACS Quality Engineer - Workstation Products
Fort Collins, Colorado, United States
$83k-$120k/yr OnsiteFull Time
4+ YOEBachelors or Masters in engineering (or equivalent experience); typically 4+ years in quality assurance/reliability; skills in root-cause analysis, ISO 9000, CAPA, data analysis, test planning, and strong communication/project management.
1w
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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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Quality Engineer II
Centennial, Colorado, United States
$81k-$111k/yr OnsiteFull Time
2+ YOEBachelor's degree or equivalent, typically 2+ years related experience, basic RCCA/CAPA knowledge, internal audit training, ability to obtain and maintain U.S. security clearance; familiarity with GD&T, IPC, and NASA requirements preferred.
Geometric Dimensioning and Tolerancing (GD&T), IPC, NASA, ISO 9001, Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC)
2w
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Quality Engineer
Englewood, Colorado, United States
$28-$41/hr OnsiteFull Time
5+ YOE5+ years quality engineering experience (aerospace/defense preferred), familiarity with AS9100/ISO9001, FAI/CAPA/MRB processes, inspection and metrology, supplier quality, ISO 9001:2015 internal auditor and IPC J-STD-001 preferred.
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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
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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.
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Senior Quality Specialist
Longmont, Colorado, United States
$111k-$126k/yr OnsiteFull Time
4+ YOERelated BA/BS required, 4+ years CDMO/pharmaceutical experience (quality preferred); strong knowledge of FDA/EU/ICH, GMP/GLP, CAPA/root cause analysis; proficiency with LIMS, Empower, MasterControl, Trackwise; strong communication and analytical skills.
LIMS, Empower, MasterControl, Trackwise, Microsoft Suite
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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