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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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
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.
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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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
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
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.
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.
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