17 capa jobs at 9 companies in Fort Collins, CO
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
5d
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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
2mo
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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
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.
1mo
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Quality Management System Manager
Boulder, Colorado, United States
$115k-$135k/yr OnsiteFull Time
5+ YOEBS required; 5+ years in quality management in advanced manufacturing; strong knowledge of ISO standards and FDA QSR; experience with NPI, root cause analysis, CAPA, supplier quality; Six Sigma/Lean preferred.
Microsoft Office, SPC, Pareto Diagrams, Affinity Diagrams, Fault-Tree Analysis, Design of Experiments
2mo
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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.
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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CLINICIAN - PROVISIONAL MUHR
Cheyenne, Wyoming, United States
OnsiteFull Time
Certification as CSW, CAP, or CAPA in Wyoming (or eligible) or Master's/PhD in counseling/clinical social work (CACREP/CORE/CSWE); conduct evaluations, individual and group counseling, complete clinical documentation; minimal travel; evenings, weekends and on-call rotation.
Microsoft Office, Zoom
2mo
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CLINICIAN - PROVISIONAL MUHR
Cheyenne, Wyoming, United States
OnsiteFull Time
Requires Wyoming CSW, CAP, or CAPA certification (or eligible), or a Master's/Ph.D. in counseling/social work from an accredited program; performs mental health and substance abuse evaluations, documents clinical records, provides individual and group counseling, supports on-call rotations, and uses Microsoft Suite/Zoom.
Microsoft Suite, Zoom
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
5d
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Quality Engineer
Boulder, Colorado, United States
$100k-$130k/yr OnsiteFull Time
3+ YOERequires a bachelor's degree or equivalent, 3+ years of quality engineering experience in manufacturing, root cause analysis, corrective actions, quality tools, data analysis, and strong communication skills.
SPC, MSA, FMEA, CAPA, 5 Why, Root Cause Analysis, Power BI, SQL, Minitab, SAP, ERP, ITAR
2mo
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ACS Quality Engineer - Workstation Products
Fort Collins, Colorado, United States
$83k-$120k/yr OnsiteFull Time
4+ YOEDesign and integrate quality requirements, analyze new product designs, perform root-cause analysis, track quality metrics; typically 4-7 years experience or advanced degree with 3-5 years.
Agile Methodology, Auditing, Automation, Computer Science, Continuous Improvement Process, Corrective And Preventive Action (CAPA), Data Analysis, Good Manufacturing Practices, ISO 9000 Series, New Product Development, Process Improvement, Product Quality (QA/QC), Project Management, Quality Management, Quality Management Systems, Risk Management, Root Cause Analysis, Test Automation, Test Planning
1w
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Production Supervisor
Windsor, Colorado, United States
$75k-$100k/yr OnsiteFull Time
3+ MgmtHigh school diploma or GED and 3+ years of leadership experience in manufacturing, production, or industrial settings. Requires production systems, ERP/MRP, Microsoft Office, Lean Manufacturing, 5S, coaching, and problem-solving skills.
Manufacturing Execution Systems (MES), ERP, MRP, Microsoft Office, 5-Why, Kaizen, Value Stream Mapping (VSM), CAPA
5d
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Quality Engineer
Boulder, Colorado, United States
$100k-$130k/yr OnsiteFull Time
3+ YOEBachelor's degree or equivalent experience, 3+ years of quality engineering in manufacturing, root cause analysis, corrective actions, quality tools, data analysis, and strong communication skills.
Statistical Process Control (SPC), Measurement Systems Analysis (MSA), Failure Mode and Effects Analysis (FMEA), Corrective and Preventive Action (CAPA), 5 Why, Root Cause Analysis, Power BI, SQL, Minitab, SAP
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