6d
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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
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.
5d
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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.
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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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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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
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
1mo
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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
1mo
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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