9 13485 jobs at 6 companies in Seattle, WA
3w
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Service Program Manager - Seattle, WA
Seattle or Idaho Falls or United States
HybridFull Time
Experience in healthcare service operations, stakeholder and vendor management, regulatory compliance (ISO 9001/13485), budget and performance monitoring, and proficiency with Microsoft Office.
Microsoft PowerPoint, Microsoft Word, Microsoft Excel, Microsoft OneNote, Microsoft Outlook, PartsSource PRO
2mo
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QC Inspector
Bothell, Washington, United States
$42k-$66k/yr OnsiteFull Time
3+ YOE3+ years QC experience in regulated industries, knowledge of ISO 13485/9001, ability to perform inspections, FAI reporting, root cause investigation, and basic statistical tools.
GD&T, CMM
3w
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Clinical Research Associate II
Seattle, Washington, United States
$83k-$114k/yr RemoteFull Time
2+ YOEBachelor's degree in life or biomedical sciences, 2 years of clinical research experience, eTMF and EDC experience, and knowledge of FDA regulations, ICH-GCP, ISO 13485, and ISO 20916.
eTMF, EDC
3w
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Supplier Quality Engineer III
Bothell, Washington, United States
HybridFull Time
5+ YOEBachelor in Electrical/Mechanical Engineering required,5+ years supplier quality experience,knowledge of FDA (820.50 & 60) and ISO 13485,CQA/CQE preferred,ability to lift 35 lbs,up to 40% travel.
PPAP
3w
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Clinical Research Associate II
Seattle, Washington, United States
$83k-$114k/yr OnsiteFull Time
2+ YOEBachelor's in life/biomedical sciences, 2+ years clinical research experience (IVD/device/pharma preferred), eTMF and EDC experience, knowledge of FDA, ICH‑GCP, ISO 13485/20916, strong communication and people management skills.
eTMF, EDC
2w
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Director, Head of Quality Management System CDx
Redmond, Washington, United States
$180k-$230k/yr OnsiteFull Time
10+ YOE5+ Mgmt10+ years quality experience in CDx/medical devices with 5+ years senior quality leadership; expertise in FDA 21 CFR 820, GMP, ISO 13485, ISO 14971; design control, supplier quality, CAPA, and inspection readiness.
3mo
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Supplier Quality Engineer
Snoqualmie, Washington, United States
$105k-$130k/yr HybridFull Time
5+ YOEBachelor's in science or engineering,5+ years supplier/manufacturing quality experience in medical devices,knowledge of ISO 13485,FDA regs,APQP/PPAP/SPC,statistical analysis,KPI development,ability to lead cross-functional teams and travel up to 30%.
APQP, PPAP, SPC, ISO 13485
2mo
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Director, Program Management
Burnaby or Bothell
$175k-$235k/yr OnsiteFull Time
10+ YOE3+ MgmtBachelor's degree required; 10+ years hardware product development (including 5+ years in program/project management), 3+ years leading program/project managers; regulated industry experience (ISO 13485), PMP/PgMP preferred, willingness to travel monthly to Bothell, WA.
3mo
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Supplier Quality Engineer
Snoqualmie, Washington, United States
$105k-$130k/yr OnsiteFull Time
5+ YOEBachelor's degree in Science or Engineering; 5+ years in manufacturing quality/ supplier quality; 5+ years medical device experience; knowledge of ISO 13485, FDA medical device regulations, cGMP, ISO 14971; data analysis and KPI development; strong communication; travel up to 30%.
APQP, PPAP, SPC, Process Validation, Statistical Methods, ISO 13485, FDA regulations