1mo
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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
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.
1mo
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Supplier Quality Engineer
Englewood, Colorado, United States
$78k-$97k/yr OnsiteFull Time
3+ YOEBachelor's degree or equivalent, 3+ years quality/sourcing experience (aerospace preferred). Experience with QMS, root cause analysis, CAPA, supplier qualification, reporting and data analysis.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook
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
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.
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.
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
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
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
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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Senior Quality Specialist
Longmont, Colorado, United States
OnsiteFull Time
4+ YOEBA/BS required; 4+ years pharmaceutical/CDMO quality experience; strong knowledge of FDA, EU, ICH, cGMP/GLP; experience with LIMS, Empower, MasterControl, Trackwise and Microsoft Suite; audit and CAPA experience.
LIMS, Empower, MasterControl, Trackwise, Microsoft Suite
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.
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
5d
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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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