31 iso 13485 jobs at 16 companies in Florida
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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.
1w
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Quality Engineer II
Clearwater, Florida, United States
OnsiteFull Time
2+ YOEBachelor's degree in engineering and 2+ years of manufacturing experience in a regulated industry. Quality systems experience preferred, including ISO 9001, cGMP, and ISO 13485.
ISO 9001, cGMP, ISO 13485, Six Sigma, World Class Manufacturing (WCM)
2mo
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Operations Project Portfolio Manager
Largo, Florida, United States
OnsiteFull Time
7+ YOEBachelor's in Engineering/Operations/Life Sciences; 7+ years PM in regulated industry; knowledge of FDA Design Controls, ISO 13485, ISO 14971, and validation.
eQMS, PLM, ERP/MRP, Quality Management System
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Quality Engineer II
Florida, United States
OnsiteFull Time
2+ YOEBachelor's degree in engineering and 2+ years of manufacturing experience in a regulated industry. Quality systems knowledge preferred, including ISO 9001, cGMP, and ISO 13485.
ISO 9001, cGMP, ISO 13485, Six Sigma, WCM, CAPA, SCAR
1mo
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Engineering Quality Manager
Brooksville, Florida, United States
OnsiteFull Time
Experience in medical-device quality engineering with knowledge of ISO 13485, ISO 9001, 21 CFR 820, SPC, PFMEA, validation, CAPA, and root cause analysis.
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
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
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WHK Quality Engineer
Clearwater, Florida, United States
$80k-$100k/yr OnsiteFull Time
3+ YOE3+ years quality engineering experience in medical device/GMP-regulated industry, experience with validations, statistical analysis, root cause problem solving, ISO 13485 knowledge, and ability to interpret blueprints.
Epicor ERP, Microsoft Office Suite
3mo
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Manufacturing Engineer
Melbourne, Florida, United States
OnsiteFull Time
3+ YOE3+ years manufacturing engineering experience; Bachelor's in engineering or equivalent experience; knowledge of QMS, ISO 13485, DFM, Lean, root cause analysis and CAPA; experience with ECOs, SOPs, and process/audit work.
ISO 13485, Lean, DFM, ECOs, SOPs, RA, CAPA
3w
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Quality Engineer
Ruskin, Florida, United States
OnsiteFull Time
5+ YOE5+ years quality/inspection experience in regulated manufacturing, knowledge of ISO 13485 and FDA 21 CFR Part 820, document control experience, GR&R and metrology skills, MS Office proficiency.
Micro-Vu, Keyence, Optical Comparators, MS Office Suite, Adobe Visio, Microsoft PowerPoint, Microsoft Excel, PivotTables, VLOOKUP
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
1mo
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Manager, Biomedical Services (FRAMINGHAM, MA, US, 01702-6358)
Framingham or Los Angeles or San Francisco or New York City or Washington or Maryland or Florida or United States
$85k-$95k/yr OnsiteFull Time
5+ YOEAssociate degree in biomedical equipment technology or electronics required; CABT/A+ preferred. Minimum 5 years hospital biomedical equipment service experience; supervisory experience, CMMS and ISO:13485 familiarity, equipment repair, calibration, and planned maintenance.
CMMS
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
2mo
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Manager, QA Operations
San Diego or Jupiter
OnsiteFull Time
3+ YOE1+ MgmtBachelor’s degree in Life Science, Biology, Chemistry or Pharmaceutical; 3-5 years managerial experience in biotech; 1-3 years supervisory; ISO 13485, 21 CFR 820 and 21 CFR 11 experience; GMP experience preferred.
2mo
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Manual Machinist
Sanford, Florida, United States
OnsiteFull Time
3+ YOE3+ years manual machining experience; operate mills, lathes, drill presses; read blueprints; use precision measuring instruments; follow FDA GMP/QSR and ISO 13485; lift up to 50 lbs; perform maintenance and quality inspections.
mills, lathes, drill presses, micrometers, calipers, gauges, indicators, hand tools, FDA GMP/QSR, ISO 13485
2mo
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Manager, QA Operations
Jupiter, Florida, United States
OnsiteFull Time
3+ YOE3+ MgmtBachelor’s degree in Life Science, Biology, Chemistry or pharmaceutical field; 3-5 years biotech management; 1-3 years supervisory experience; ISO 13485, 21 CFR 820, 21 CFR 11; GMP experience preferred; strong communication, problem solving, and teamwork.
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