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FDA Laboratory Technician full time
Denver, Colorado, United States
OnsiteFull Time
Supports media and glassware preparation, autoclaving and MPW handling per USP/EPA/OSHA/FDA; ability to prepare media and bulk solutions; favorable Tier 2/Public Trust background investigation required.
1mo
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Director of Quality Engineering
Centennial, Colorado, United States
$140k-$170k/yr HybridFull Time
Leadership in quality engineering for medical device/Class I products; QMS ownership; FDA and ISO 13485 regulatory oversight; process improvement (Lean/Six Sigma); drive defect prevention and audit readiness.
Lean/Six Sigma, Quality Management System (QMS), ISO 13485, FDA
2mo
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Research Services Clinical Sciences Senior Professional (Onsite)
Aurora, Colorado, United States
$59k-$75k/yr OnsiteFull Time
2+ YOESenior clinical research professional with leadership across studies, regulatory expertise (GCP/IRB/FDA), data management, and study operations.
REDCap, Excel, Regulatory Submissions
2mo
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Project Engineer 3
Marlborough or Louisville
$98k-$153k/yr OnsiteFull Time
3+ YOEBachelor’s degree in Engineering; 3+ years project management; regulated medical device experience preferred; FDA/ISO knowledge; PMP preferred.
PMO tools, Gantt charts, risk registers, design history file (DHF) documentation
3w
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Paramedic/EMT-P
Aurora, Colorado, United States
$28-$39/hr OnsiteFull Time
2+ YOEState EMT-Paramedic license, CPR and AED certification, basic IV therapy, FDA training completion, and 2 years clinical or hospital experience.
1mo
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Production Technician - Golden (CO)
Golden, Colorado, United States
$19-$22/hr OnsiteFull Time
Perform compounding, in-process sampling/testing, equipment operation, and manufacturing paperwork while following GMP/SOP to meet FDA, USP, cGMP and cGDP standards.
blenders, tablet presses, tablet Deduster, scales, hardness testers, metal detector, tablet counter, capsule making equipment, magnifying lenses, mixer, hot plates, Microsoft Word, Microsoft Excel
20h
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Senior Quality Control Specialist
Boulder, Colorado, United States
$128k-$155k/yr OnsiteFull Time
4+ YOE4+ years QC experience in biotech/pharma (GMP) with ability to perform analytical methods, interpret stability data, and follow FDA/ICH cGMP requirements.
IP-RP-UPLC, SAX-HPLC, GC, Mass Spec, FTIR, UV
1w
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QA Lab Technician - Englewood, CO
Englewood, Colorado, United States
$24-$30/hr OnsiteFull Time
Perform laboratory and QA testing of sterilization indicators, operate lab equipment, document results, maintain quality records, and follow FDA/ISO procedures in a regulated environment.
Microsoft Word, Microsoft Excel, Microsoft Outlook
2w
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Operations Technician
Golden, Colorado, United States
$25-$27/hr OnsiteFull Time
2+ YOE2+ years manufacturing/inspection experience preferred, FDA/ISO 13485 familiarity, electronics and test equipment experience, strong attention to detail, computer skills, English proficiency.
1w
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Prin Regulatory Affairs Spec
North Haven or Mansfield or Mounds View or Boston or Lafayette
$120k-$180k/yr OnsiteFull Time
7+ YOEBachelor's degree and 7+ years regulatory experience (or advanced degree with 5+ years). Experience with 510(k), FDA interactions, international registrations, labeling and promotional material review.
2w
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Key Account Principal Clinical Specialist
Denver or United States
$87k-$173k/yr RemoteFull Time
3+ YOEAdvanced degree required, 3+ years EP industry experience, proficiency in Salesforce and PowerBI, willingness to travel ~50%, knowledge of FDA regulations, strong organization and multitasking skills.
Salesforce, PowerBI
2mo
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Associate Director of Quality
Englewood, Colorado, United States
$130k-$160k/yr OnsiteFull Time
5+ YOE3+ MgmtLead quality assurance in a 503B facility; 5+ years QA; 3+ years leadership; US FDA cGMPs experience; bachelor's in related field; strong leadership and documentation.
Microsoft 365, Excel, Outlook
1w
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Clinical Operations Manager II
Aurora, Colorado, United States
$72k-$88k/yr RemoteFull Time
4+ YOE2+ Mgmt4 years clinical research experience with 2 years project/operations management, knowledge of GCP/FDA/ICH, proficiency in Microsoft Office, strong communication and organizational skills.
Microsoft Outlook, Microsoft Word, Microsoft Excel
3w
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Product Packaging Team Member, Bakehouse
Aurora, Colorado, United States
$19-$31/hr OnsiteFull Time
Pack products to specification, follow USDA/FDA/OSHA and facility food-safety procedures, operate packaging equipment, accurately label and document product, and lift up to 50 lbs.
box maker, shrink tunnel, metal detector, forklift, pallet jacks, hand trucks, six-wheel carts, baler
1mo
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First Cook
Denver, Colorado, United States
$23/hr OnsiteFull Time
2+ YOE2 years experience; knowledge of mother sauces and multiple cooking methods; ability to follow recipes, comply with FDA/HACCP, communicate effectively, work under pressure, and be flexible on schedule.
1mo
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Research Nurse
Denver, Colorado, United States
$83k-$100k/yr OnsiteFull Time
1+ YOEActive RN license, knowledge of clinical research processes, FDA CFR and GCP, 1+ year oncology experience preferred, research experience and research certification (ACRP/CCRP) preferred.
1w
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Plant Manager
Denver or Clinton Township
OnsiteFull Time
10+ YOE10+ years leadership in injection molding or advanced manufacturing, expertise in scientific molding, Lean/Six Sigma, regulated environments (ISO 13485/FDA/ITAR), automation and financial management.
RJG, Lean Manufacturing, Six Sigma
2w
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Senior Process Development Engineer
Lakewood, Colorado, United States
$89k-$111k/yr OnsiteFull Time
5+ YOEBachelor's degree in engineering, 5+ years process development/manufacturing engineering experience, expertise in process optimization, regulatory compliance (GMP/FDA/ISO), and strong leadership and communication skills.
Aspen Plus, COMSOL, Minitab, MATLAB
3mo
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FSQA Manager
Denver, Colorado, United States
$86k-$142k/yr OnsiteFull Time
5+ YOE1+ Mgmt5+ years in food manufacturing/FSQA; Bachelor's in Food Science, Microbiology, Engineering, or related field; strong FDA/USDA, FSMA, HACCP knowledge; proven problem-solving and leadership.
3w
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Staff Software Engineer, Valence
Louisville, Colorado, United States
$130k-$145k/yr OnsiteFull Time
8+ YOE8+ years in surgical navigation or medical device software; proficiency in C++ on Linux, 3D geometry and imaging, image processing toolkits, experience in FDA-regulated environments, strong leadership and communication.
C++, Linux, Qt, DICOM, VTK, ITK, OpenCV, GIT, Azure DevOps
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