18 iso 13485 jobs at 9 companies in Greeley, CO
1mo
Save
Mark Applied
Hide
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
Save
Mark Applied
Hide
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
1mo
Save
Mark Applied
Hide
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
Save
Mark Applied
Hide
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
1mo
Save
Mark Applied
Hide
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
2mo
Save
Mark Applied
Hide
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
3w
Save
Mark Applied
Hide
Mechanical Engineer III - Advanced Surgical
Denver, Colorado, United States
$82k-$125k/yr OnsiteFull Time
5+ YOEBS in Mechanical/Biomedical Engineering, 5+ years product development experience, SolidWorks CAD proficiency, regulated environment experience (21 CFR 820/ISO 13485), design control and risk management knowledge.
SolidWorks
2mo
Save
Mark Applied
Hide
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
2mo
Save
Mark Applied
Hide
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
Save
Mark Applied
Hide
Territory Sales Manager, SLC, Utah/Denver, Colorado
United States or Denver
FieldFull Time
5+ YOE5+ years medical device sales experience in neurovascular or related sectors, bachelor’s degree, familiarity with FDA QSR and ISO 13485, proven sales track record, strong communication and presentation skills, willingness to travel extensively.
Microsoft PowerPoint, Microsoft Word, Microsoft Excel
1mo
Save
Mark Applied
Hide
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
1mo
Save
Mark Applied
Hide
Territory Sales Manager, SLC, Utah/Denver, Colorado
United States or Denver or Salt Lake City
FieldFull Time
5+ YOE5+ years medical device sales experience in neurovascular or related sectors, bachelor\u0002s degree, knowledge of FDA QSR/ISO 13485, strong clinical/technical aptitude, quota-driven sales success, extensive travel, Microsoft Office proficiency.
Microsoft PowerPoint, Microsoft Word, Microsoft Excel
1mo
Save
Mark Applied
Hide
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
Save
Mark Applied
Hide
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.
1mo
Save
Mark Applied
Hide
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.
1mo
Save
Mark Applied
Hide
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
Save
Mark Applied
Hide
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
Save
Mark Applied
Hide
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
Explore Jobs
Expand Your Job Search
Top Cities Near Greeley for Iso 13485
- Iso 13485 jobs in Denver, CO
- Iso 13485 jobs in Aurora, CO
- Iso 13485 jobs in Fort Collins, CO
- Iso 13485 jobs in Thornton, CO
- Iso 13485 jobs in Westminster, CO
- Iso 13485 jobs in Arvada, CO
- Iso 13485 jobs in Boulder, CO
- Iso 13485 jobs in Longmont, CO
- Iso 13485 jobs in Loveland, CO
- Iso 13485 jobs in Broomfield, CO
- Iso 13485 jobs in Cheyenne, WY
- Iso 13485 jobs in Commerce City, CO
- Iso 13485 jobs in Northglenn, CO
- Iso 13485 jobs in Brighton, CO
- Iso 13485 jobs in Wheat Ridge, CO
- Iso 13485 jobs in Lafayette, CO
- Iso 13485 jobs in Windsor, CO
- Iso 13485 jobs in Erie, CO
- Iso 13485 jobs in Evans, CO
- Iso 13485 jobs in Louisville, CO