15 iso 13485 jobs at 7 companies in Windsor, CO
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Quality Assurance Manager
Louisville or Pennsylvania
$120k-$140k/yr OnsiteFull Time
5+ YOE5+ years QMS management with ISO 9001/ISO 13485/MDSAP experience, audit experience, ITAR knowledge, intermediate-to-expert Microsoft Office skills, bachelor’s degree preferred (engineering).
Microsoft Office
1w
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Prin Quality Engineer
Lafayette or North Haven or Boston or Minneapolis or Los Angeles County
$121k-$181k/yr OnsiteFull Time
Bachelor's degree in engineering or related technical field; in-depth FDA, ISO 13485, and ISO 14971 knowledge; quality, risk management, regulatory, statistics, root-cause analysis, leadership, and project management expertise.
FDA, ISO 13485, ISO 14971, ISO 62304, FDA Part 820, Design Failure Modes and Effects Analyses (DFMEAs), Process FMEA, User FMEA
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Senior Embedded Software Engineer
Lafayette, Colorado, United States
$117k-$175k/yr OnsiteFull Time
5+ YOEBachelor's (5+ yr) or Master's (3+ yr) plus expertise in C/C++, Embedded Linux, hardware integration, debugging, and regulated development; familiarity with IEC 62304/ISO 14971/ISO 13485 preferred.
C, C++, Embedded Linux, USB, UART, I2C, SPI, Qt, LVGL, Python, Shell
3w
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Design Quality Engineer II
Lafayette, Colorado, United States
$79k-$119k/yr OnsiteFull Time
2+ YOEBachelor's in engineering or related plus 2 years relevant quality/regulated industry experience; familiarity with QMS, ISO 13485, ISO 14971, design controls, risk management, V&V, CAPA, and cross-functional communication.
Minitab
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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
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Sr Design Quality Engineer
Lafayette, Colorado, United States
$98k-$148k/yr OnsiteFull Time
4+ YOEBachelor's degree plus 4+ years quality experience (2+ with MS). Experience in medical device/regulated environments, ISO 13485/FDA QSR/EU MDR, ISO 14971 risk management, design controls, V&V, CAPA, and electronic hardware experience.
Minitab
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Sr Design Quality Engineer
Lafayette, Colorado, United States
$98k-$148k/yr OnsiteFull Time
4+ YOEBachelor's degree and 4+ years quality experience (2+ with Master's), medical device or regulated-industry experience, knowledge of ISO 13485/21 CFR 820/EU MDR, ISO 14971 risk management, verification/validation, CAPA and failure analysis, PCB/electronic hardware experience, and strong communication.
Minitab
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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
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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
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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.
2mo
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Principal, RA Specialist
Boulder or Remote
$110k-$135k/yr RemoteFull Time
7+ YOEBachelor’s degree in a technical field; 7+ years in regulated environment; 4+ years global regulatory experience (IVD); US FDA/EU IVDR/510(k) knowledge; Design Control and Risk Management experience; ISO 13485 experience; strong collaboration and leadership.
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Senior Compliance/Audit Manager
Minneapolis or Irvine or North Haven or Memphis or Lafayette
$146k-$218k/yr OnsiteFull Time
7+ YOE5+ MgmtBachelor's +7 years in quality/regulatory/compliance in medical device or regulated healthcare, 3+ years auditing, 5+ years managerial experience, Certified Lead Auditor, expertise in MDSAP, FDA QMSR/21 CFR, ISO 13485, inspection readiness, and stakeholder engagement.
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Senior Compliance/Audit Manager
Minneapolis or Irvine or North Haven or Memphis or Lafayette
$146k-$218k/yr OnsiteFull Time
7+ YOE5+ MgmtBachelor's degree plus 7+ years in quality/regulatory/compliance in medical device or regulated healthcare, 3+ years audit experience, 5+ years managerial experience, Certified Lead Auditor (or equivalent) preferred, familiarity with MDSAP, FDA QMSR/21 CFR, ISO 13485.
3mo
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Senior Software Engineer (Loveland, CO)
Loveland, Colorado, United States
$107k-$134k/yr OnsiteFull Time
5+ YOEFive or more years in professional software development; strong C++ and embedded Linux experience; DevOps (Docker, GitLab CI); cloud infrastructure (AWS/Azure); GUI with Qt; Yocto; LIMS/EHR connectivity; regulated software (IEC 62304 FDA QSR ISO 13485).
C++, Embedded Linux, Docker, GitLab CI, AWS, Azure, Qt, Yocto
2mo
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Sr. Mechanical Engineer -
Lafayette or United States
$106k-$160k/yr HybridFull Time
4+ YOEBachelor's in Mechanical Engineering (or advanced degree), 4+ years medical device/product development experience (Masters/PhD acceptable with reduced experience), knowledge of FDA 21 CFR Part 820, ISO 13485/14971, design controls, DHF, NPI, RCA, CAD (SolidWorks/Creo/NX).
SolidWorks, Creo, NX