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15 iso 13485 jobs at 8 companies in Washington, DC

5d
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Sr. Development Engineer
Allendale or Leesburg
$100k-$110k/yr OnsiteFull Time
VB Spine
VB Spine: A privately held medical technology developing products for spinal surgery and spine care.
2+ YOEBachelor's degree in mechanical, biomedical, or related engineering; 2+ years of product development experience; CAD proficiency; FDA design controls, ISO 14971, and ISO 13485 knowledge.
CAD, SolidWorks, Creo, FDA design controls, ISO 14971, ISO 13485
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5d
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Sr. Development Engineer
Leesburg or Allendale
OnsiteFull Time
VB Spine
VB Spine: A privately held medical technology developing products for spinal surgery and patient care.
2+ YOEBachelor's degree in mechanical, biomedical, or related engineering; 2+ years of product development experience; CAD proficiency; FDA design controls, ISO 14971, and ISO 13485 knowledge.
SolidWorks, Creo, CAD, FDA design controls, ISO 14971, ISO 13485
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2mo
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Quality Engineer
Alexandria, Virginia, United States
OnsiteFull Time
MPR Associates
MPR Associates: Independent engineering and consulting services provider across power, federal, and life sciences sectors.
2+ YOEBachelor's in a technical field; 2+ years in engineering/manufacturing; QA audits and process improvement experience; US citizenship required; ASME NQA-1, ISO 13485, or ISO 9001 experience desirable; MS Office proficiency.
Microsoft Office
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2mo
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Global Supplier Quality Engineer II
Columbia or Princeton
$71k-$98k/yr OnsiteFull Time
Integra LifeSciences
Integra LifeSciencesNASDAQ: IART: Manufacturing surgical instruments and regenerative medical technology devices.
3+ YOEBachelor’s or master’s degree in engineering; minimum 3 years quality/manufacturing; medical device or pharma experience; ISO 9001/13485, 21 CFR 820; travel up to 25%.
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1w
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Medical Device Reliability and Design Engineer
Bethesda, Maryland, United States
OnsiteFull Time
Tunnell Government Services
Tunnell Government Services: Provides specialized scientific and technical consulting for government agencies.
15+ YOEMaster's or equivalent in engineering or related science; 15+ years of IVD industry experience; expertise in diagnostics, device development, manufacturing, FDA processes, Design Control, quality systems, and ISO 13485.
Quality Management System, Design Control, Quality Systems Management, ISO 13485, FDA current Good Manufacturing Practices (cGMP)
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2mo
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Sr. Director, Clinical Development
Palo Alto or Baltimore
HybridFull Time
DELFI Diagnostics
DELFI Diagnostics: Developing blood-based tests for early cancer detection.
8+ YOE6+ MgmtPhD or MD required; 8+ years leading clinical study design and development; 3–5 years IVD diagnostics experience; 6+ years management; knowledge of ICH E6(R3) GCP, ISO 14155, ISO 13485, 21 CFR Part 820; oncology preferred.
NLP, LLM, EHR, FAIR principles, FHIR-OMOP, Common Data Models
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1mo
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Sr. Development Engineer
Leesburg or Allendale
$100k-$110k/yr OnsiteFull Time
VB Spine
VB Spine: A medical technology focused on developing spinal surgery devices and visualization platforms.
2+ YOEB.S. in Mechanical/Biomedical Engineering required (M.S. preferred), 2+ years product development experience (medical device preferred), CAD proficiency, knowledge of FDA design controls and ISO 14971/13485.
SolidWorks, Creo
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1mo
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Sr. Quality Engineer
Leesburg, Virginia, United States
$100k-$110k/yr OnsiteFull Time
VB Spine
VB Spine: A medical technology that develops and manufactures spinal implants and instruments to improve patient outcomes.
3+ YOEBachelor’s in Engineering, 3+ years quality engineering in medical device or regulated manufacturing, knowledge of risk management, CAPA, audits, ISO 13485/FDA QSR/EU MDR, supplier control, and ERP systems.
ERP
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2w
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Sr. Quality Engineer
Allendale or Leesburg
$95k-$110k/yr OnsiteFull Time
VB Spine
VB Spine: A medical technology focused on developing and manufacturing spine products that improve patient outcomes.
3+ YOEBachelor's degree in engineering, 3+ years quality experience in medical device or regulated manufacturing, strong knowledge of risk management, CAPA, audits, validation, supplier controls, and regulatory requirements (ISO 13485, FDA QSR).
Measurement System Analysis (MSA)
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1mo
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Senior / Principal Scientist, QC and Analytical Development
Baltimore, Maryland, United States
OnsiteFull Time
LifeSprout
LifeSprout: Developing regenerative biomaterials for aesthetic and reconstructive medicine.
5+ YOEHands-on experience developing and validating analytical, chemical, physical, and mechanical methods for biomaterials; MS required (PhD desirable); 5+ years senior-level experience; GMP/ISO 13485 experience; strong technical writing.
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1mo
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Vice President, Quality - Pharma & Diagnostics
Chantilly or Clifton or San Juan Capistrano or Secaucus
$300k-$350k/yr HybridFull Time
Quest Diagnostics
Quest DiagnosticsNYSE: DGX: Provides clinical laboratory diagnostic testing and health information services.
15+ YOE10+ Mgmt15+ years leadership in regulated healthcare/pharma/device quality; expert knowledge of FDA QMSR and ISO 13485; 10+ years managing multi-site quality teams; Bachelor’s required, advanced degree preferred.
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2w
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Sr. Quality Engineer
Leesburg or Allendale
$95k-$110k/yr OnsiteFull Time
VB Spine
VB Spine: A privately held medical technology focused on spinal products and improving patient outcomes.
3+ YOEBachelor's in engineering, minimum 3 years quality experience in medical device or regulated manufacturing, knowledge of risk management, CAPA, audits, ISO 13485 and FDA QSR, root cause analysis, supplier control, and statistical process control.
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1mo
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Senior / Principal Process Development Engineer
Baltimore, Maryland, United States
OnsiteFull Time
LifeSprout
LifeSprout: Developing regenerative biomaterials for aesthetic and reconstructive medicine.
5+ YOEHands-on process development, scale-up, optimization, and validation experience for regulated polymeric/biomaterial or medical device manufacturing; DOE and statistical analysis experience; working knowledge of GMP and ISO 13485; BS/MS in engineering or related field.
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2mo
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Regulatory Affairs Specialist (Innovation)
Sparks, Maryland, United States
$96k-$153k/yr OnsiteFull Time
BD
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
5+ YOEBachelor's in a related scientific/technical field, minimum 5 years regulatory experience in IVD/medical devices, experience preparing FDA and EU IVDR submissions, familiarity with ISO 13485, strong communication and cross-functional collaboration skills.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, ISO 13485
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2mo
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Staff Engineer
Allendale or Leesburg
$128k-$136k/yr OnsiteFull Time
VB Spine
VB Spine: A medical technology designing spinal implants and instruments and supporting surgeons during spinal procedures.
4+ YOEBachelors in Mechanical/Biomedical Engineering required (Master's preferred), 4+ years medical device product development experience, proficiency with parametric CAD (Creo or SolidWorks), GD&T, experience with design controls and regulated industry standards (FDA, ISO 13485).
Creo, SolidWorks, GD&T
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