5d
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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
1mo
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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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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
2mo
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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
3w
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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.
2w
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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.
4d
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Supplier Quality Engineer II
Boulder, Colorado, United States
$80k-$120k/yr OnsiteFull Time
2+ YOEBachelor's degree and minimum 2 years relevant experience (or Master's with 0 years). Experience in supplier quality, root cause analysis, CAPA, and project management; strong communication skills.
Microsoft Office, ERP
1w
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Senior Quality Engineer – CST – Lafayette, CO (Onsite)
Lafayette, Colorado, United States
$98k-$148k/yr OnsiteFull Time
4+ YOEBachelor's in engineering or technical discipline with 4+ years (or Master's with 2+, PhD with 0+) experience; experience with CAPA, audits, root cause analysis, quality systems, and regulatory expectations for medical devices.
1mo
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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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QC Technical Compliance Specialist
Fort Collins or Colorado
$95k-$100k/yr HybridFull Time
6+ YOEBS in chemistry/biochemistry/pharmaceutical sciences required, 6+ years cGMP QC lab experience, strong knowledge of CAPA, ALCOA+, cGMP, root cause analysis, documentation, and technical report authoring.
Veeva, Microsoft Office
1w
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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
2w
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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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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
1mo
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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.
3w
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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
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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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
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