9 iso 13485 jobs at 7 companies in Phoenix, AZ
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Senior Design Quality Engineer
Phoenix, Arizona, United States
HybridFull Time
4+ YOEBachelor's in engineering; 4+ years in design controls; ISO 13485, CFR 820, ISO 14971; regulator knowledge; experience with eQMS.
eQMS, Quality Management Systems, Regulatory Standards
1mo
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Quality Engineer - United States
Phoenix, Arizona, United States
OnsiteFull Time
2+ YOEBachelor's in engineering or science, 2+ years engineering experience in manufacturing, supplier quality experience, familiarity with ISO 9001 or ISO 13485, and experience supporting audits and root-cause investigations.
SAP
3mo
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Rapid Prototyping Program Manager (Mitsubishi Chemical Advanced Materials)
Mesa, Arizona, United States
$103k-$129k/yr OnsiteFull Time
10+ YOE7+ MgmtBachelor's degree or equivalent; 10+ years manufacturing; 7+ years leadership; CNC machining and plastics; ISO 9001, AS9100, ISO 13485; ERP/MRP experience; strong customer-facing skills.
CNC machining, plastsics manufacturing, ERP/MRP
3w
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Quality Systems Specialist
Scottsdale, Arizona, United States
OnsiteFull Time
1+ YOEBachelor's in a technical field and 1+ year experience; knowledge of FDA QSR, ISO 13485, ISO 14971, GMP; auditor skills, root cause analysis, strong communication, and Microsoft Office Project proficiency.
Microsoft Office Word, Microsoft Office Excel, Microsoft Office PowerPoint, Microsoft Office Project
2mo
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Senior Manager IT Manufacturing Applications
Mesa, Arizona, United States
$142k-$236k/yr RemoteFull Time
13+ YOE6+ Mgmt10+ years in manufacturing systems, leadership experience, GMP/GxP/ISO 13485 knowledge, FDA 21 CFR Parts 11 & 820, ML/AI for manufacturing preferred, Six Sigma strongly preferred.
GCP, Machine Learning, AI for Manufacturing, Gemini Enterprise, Agentic AI, Predictive Maintenance
3w
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Quality Engineer
Scottsdale, Arizona, United States
OnsiteFull Time
3+ YOEBachelor's in a technical field and minimum 3 years' experience; knowledge of FDA CFR 21 820 and ISO 13485; Minitab and Microsoft Office proficiency; ability to write technical documents and perform risk analysis.
Minitab, Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Project
1mo
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Quality Inspector
Mesa, Arizona, United States
$21-$27/hr OnsiteFull Time
High school diploma, experience with precision measurement (micrometers, calipers, gage blocks), GD&T knowledge preferred, ability to read blueprints, follow QMS procedures (ISO 9001/13485/AS9100), and document inspections.
micrometers, calipers, gage blocks
3w
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Senior Supply Chain Analyst
Tempe, Arizona, United States
OnsiteFull Time
3+ YOE3+ years procurement/strategic sourcing or supply planning experience in regulated manufacturing; hands-on ERP/MRP experience; supplier negotiation and cost-savings track record; ISO 13485 familiarity; strong analytical and communication skills.
NetSuite, SAP, Oracle, Microsoft Dynamics, Microsoft Outlook, Microsoft Word, Microsoft Excel
2mo
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Senior Manager- Manufacturing IT Strategic Initiatives and Architecture
Mesa, Arizona, United States
$142k-$236k/yr HybridFull Time
10+ YOE5+ Mgmt10+ years managing manufacturing systems, experience with ML/AI and GCP preferred, knowledge of GMP/GxP, ISO 13485 and FDA 21 CFR Parts 11 & 820, people management experience, Bachelor's in a technical discipline typically required.
Machine Learning, GCP, Agentic AI, Gemini Enterprise, Vertix