15 iso 13485 jobs at 6 companies in Miami, FL
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Quality Assurance & Compliance Intern (FL, Miramar)
Miramar, Florida, United States
OnsiteInternship
Internship supporting quality documentation, document control, validation records, revision controls, and ISO 9001 and ISO 13485 compliance in a manufacturing environment.
Quality Management System (QMS)
2mo
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Quality Engineer Device Development (Deerfield Beach, FL, US)
Deerfield Beach, Florida, United States
OnsiteFull Time
2+ YOEBachelor's in science/engineering; 2+ years quality engineering; knowledge of ISO 13485, QSR, ISO 14971, IEC62366, IEC62304; cross-functional collaboration.
1mo
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Design Engineer
Deerfield Beach, Florida, United States
OnsiteFull Time
2+ YOE2+ years design experience; BS in Mechanical or Biomedical Engineering; Solidworks and FEA proficiency; statistical and tolerance analysis; injection molding and FMEA knowledge; familiarity with 21 CFR Part 820, ISO 13485, ISO 11608, ISO 14971; travel >10%.
Solidworks, Finite Element Analysis
1w
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Development Scientist II
Miami, Florida, United States
OnsiteFull Time
Experience in FDA/ISO 13485 environments; Excel and JMP proficiency; knowledge of chemistry, microscopy, engineering, reagent manufacturing, laboratory equipment, and statistical methods; ability to lift 40 lbs.
Microsoft Excel, JMP, pH meter, Osmometer, Conductivity Meter, Spectrophotometer, Beckman Coulter Particle Counter
3mo
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Manufacturing Group Leader (Sunrise, FL, US, 33325)
Sunrise, Florida, United States
OnsiteFull Time
5+ YOE1+ Mgmt5+ years direct medical device manufacturing; 1+ year supervisory; knowledge of quality systems (21 CFR 820, ISO 13485); SAP and inventory management knowledge preferred.
SAP, Inventory management
2mo
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Service Program Manager - Ft. Lauderdale Fl
Fort Lauderdale, Florida, United States
OnsiteFull Time
Bachelor’s degree or equivalent healthcare experience; experience in healthcare service operations; regulatory compliance knowledge (ISO 9001/13485); vendor and customer relationship management; proficient in Microsoft Office.
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Senior Development Scientist
Miami, Florida, United States
OnsiteFull Time
2+ YOEDegree in cell biology, chemistry, or biochemistry plus 2–5+ years relevant experience; industry R&D experience; multidisciplinary teamwork; FDA/ISO 13485 experience preferred.
Microsoft Excel, JMP, pH meter, Osmometer, Conductivity Meter, Spectrophotometer, Beckman Coulter Particle Counter
3mo
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Manager, Quality Control (TAS) (Sunrise, FL, US, 33325)
Sunrise, Florida, United States
OnsiteFull Time
8+ YOEOversee QA/QC staff; ensure ISO 13485 and 21 CFR 820 compliance; lead investigations and CAPAs; manage QA/QC across receiving, in-process, and finished product.
SAP
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Development Scientist II
Miami, Florida, United States
OnsiteFull Time
Requires FDA/ISO 13485 experience, statistical methods, Excel and JMP proficiency, laboratory testing knowledge, and chemistry, microscopy, engineering, or reagent manufacturing experience. Must lift 40 lbs.
Microsoft Excel, JMP, pH meter, Osmometer, Conductivity Meter, Spectrophotometer, Beckman Coulter Particle Counter
2w
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Quality Assurance Specialist
Deerfield Beach, Florida, United States
OnsiteFull Time
4+ YOE4+ years quality experience in pharmaceutical or medical device GMP manufacturing; BS in engineering/biology preferred; knowledge of 21 CFR, ISO 13485, GxP and documentation practices; audit and technical writing experience.
1w
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Senior Development Scientist
Miami, Florida, United States
HybridFull Time
2+ YOEDegree in cell biology, chemistry, or biochemistry plus 2–5+ years of relevant experience; industry R&D experience and multidisciplinary teamwork required. FDA/ISO 13485, statistical analysis, and laboratory equipment experience preferred.
Microsoft Excel, JMP, pH meter, Osmometer, Conductivity Meter, Spectrophotometer, Beckman Coulter Particle Counter
2mo
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Design Controls Specialist
Miramar, Florida, United States
OnsiteFull Time
3+ YOEBachelor's in relevant field, 3+ years experience in medical device/pharmaceutical industries, strong knowledge of FDA 21 CFR Part 820/4, ISO 13485/14971, design verification/validation, and document control (TrackWise).
TrackWise
2mo
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Molding Process Engineer
Tamarac, Florida, United States
OnsiteFull Time
3+ YOEBachelor's in engineering or equivalent, 3+ years plastics/polymer processing experience, strong process development, polymer knowledge, process validation, data/root cause/statistical analysis, and regulated environment experience (GMP/ISO 13485/FDA).
ERP, MES
3w
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Production Supervisor (TAS)
Sunrise, Florida, United States
OnsiteFull Time
3+ YOE3+ MgmtSupervisory manufacturing experience, knowledge of quality/regulatory systems (ISO 13485, 21 CFR 820, MDSAP), Lean manufacturing, Microsoft Excel/Word and SAP/ERP, ability to lead teams and drive safety, quality, productivity and continuous improvement.
Microsoft Excel, Microsoft Word, SAP/ERP systems
1mo
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Supervisor, Quality Control (TAS)
Sunrise, Florida, United States
$72k-$100k/yr OnsiteFull Time
5+ YOESupervise QC inspectors, analyze trends, manage non-conformances/CAPA, ensure compliance with ISO 13485 and 21 CFR Part 820, conduct audits, and support validations; BS in Engineering or 5+ years medical device quality experience preferred.
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