2mo
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Supervisor, Quality control (TAS) (Sunrise, FL, US, 33325)
Sunrise, Florida, United States
OnsiteFull Time
5+ YOESupervise QC inspectors, analyze trends, implement CAPA, ensure ISO13485/21 CFR820 compliance.
Sampling plans, CAPA system, ISO 13485, 21 CFR Part 820
1mo
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Sr. Quality Systems Engineer (TAS)
Sunrise, Florida, United States
OnsiteFull Time
5+ YOEBachelor's in technical discipline and minimum 5 years medical device quality assurance experience. Knowledge of ISO 13485, 21 CFR 820 and 21 CFR Part 11, CSV, CAPA, DOE/SPC/Gage R&R, validation, risk assessment, and strong communication and analytical skills.
ISO 13485, 21 CFR Part 820, 21 CFR Part 11, Computerized System Validation (CSV), DOE, SPC, Gage R&R, CAPA, Quality Management System (QMS)
3mo
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Quality Engineer II (TAS) (Sunrise, FL, US, 33325)
Sunrise, Florida, United States
OnsiteFull Time
5+ YOESupport quality engineering operations for receiving, in-process, and finished product; maintain regulatory compliance; develop qualification/validation protocols; lead CAPA and continuous improvement.
SAP, DOE, SPC, Gage R&R, Sampling plans
1d
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Quality Assurance Specialist
Boca Raton, Florida, United States
OnsiteFull Time
Experience in regulated manufacturing with strong knowledge of GMP, QMS, CAPA, deviations, document control and SOPs; analytical skills and English proficiency; bachelor's degree preferred.
eQMS
3w
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Lead Quality Technician (FL, Miramar)
Miramar, Florida, United States
OnsiteFull Time
Senior quality role overseeing inspections, testing, non-conformance management, CAPA, calibration, mentoring technicians, and participating in continuous improvement in an LSR injection molding facility.
calipers, micrometers, optical comparator, coordinate measuring machine (CMM), QMS, Six Sigma, Lean
2mo
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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
3w
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Senior Project Engineer
Boca Raton, Florida, United States
OnsiteFull Time
10+ YOE10+ years engineering experience in cGMP pharmaceutical/biological manufacturing; project management, commissioning, P&ID review, load calculations, CAPA documentation, strong technical writing and Microsoft Office skills.
Microsoft Word, Microsoft Excel, Microsoft Project
1w
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Quality Systems & Compliance Manager
Fort Lauderdale, Florida, United States
$90k-$120k/yr HybridFull Time
3+ YOE3–7 years quality or manufacturing experience, ISO 9001:2015 experience, strong technical writing, document control, audit and CAPA skills, ability to interpret technical drawings, Microsoft Office proficiency.
Microsoft Office Suite, SharePoint, Microsoft Power Platform, ERP
1mo
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Commissioning and Qualification Engineer
Tamarac or Miramar
$85k-$95k/yr OnsiteFull Time
2+ YOEBachelor's in engineering (Master's preferred), 2+ years commissioning and qualification experience in pharmaceutical/medical device, GMP/CFR/ICH knowledge, statistics/DoE, CAPA and project management, proficient with Word/Excel/Project/Minitab.
Microsoft Word, Microsoft Excel, Microsoft Project, Minitab
3mo
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Quality Assurance Engineer II
Miami, Florida, United States
OnsiteFull Time
3+ YOEBachelor’s in engineering or related technical field; 3-4 years in engineering or quality; knowledge of FDA, AATB, ISO 13484, cGTP; experience in tissue banking/pharma/biologics; CAPA experience; strong software skills.
Microsoft Project, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
1mo
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Engineer II, Quality
Miami, Florida, United States
$83k-$104k/yr OnsiteFull Time
BS in engineering/biomedical/biological sciences; knowledge of electronic QMS, GMP/GTP, quality tools (FMEA, DMAIC, 5-Whys), ERP and MS Office; support CAPA, investigations, change control, audits, and CoA review.
6Ms, 5-Why's, FMEA, DMAIC, Cause and Effect Diagrams, Process Mapping, Electronic Quality Management Systems, ERP, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
5d
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Product Quality Engineer
Atlanta or Houston or Miami or Tysons or United States
RemoteFull Time
5+ YOEBachelor's in engineering,5+ years quality engineering in energy/power,experience leading FATs for electrical equipment,knowledge of ISO 9001/NCR/RCA/CAPA,ability to read electrical/civil drawings,and willingness to travel up to 75%.
1w
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Director of Service Quality
Houston or Miami
OnsiteFull Time
10+ YOE5+ MgmtBachelor's degree in engineering or related field,10+ years in service/field/product quality,5+ years people leadership,experience with root cause analysis,NCR/CAPA and ISO 9001,quality certifications preferred,ability to travel.
QMS, ERP, CRM
1mo
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Sr. Quality Assurance Engineer
Miami, Florida, United States
OnsiteFull Time
5+ YOEBachelor's in engineering or related, 5+ years QA/engineering experience in tissue banking/biologics/pharma/device, CAPA and root-cause experience, knowledge of FDA/AATB/cGTP guidelines, Microsoft Project/Word/Excel/PowerPoint proficiency.
Microsoft Project, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
3w
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Specialist QA II Manufacturing Oversight
Boca Raton, Florida, United States
OnsiteFull Time
3+ YOE3+ years pharma/biotech QA experience preferred, knowledge of quality systems (Deviations, CAPA, Change Control, OOS), cGMP and 21 CFR, experience with LIMS/SAP preferred, strong communication and organizational skills; Bachelor's degree preferred.
LIMS, SAP
3w
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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.
2mo
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Quality Assurance Director
Miami, Florida, United States
OnsiteFull Time
10+ YOE5+ Mgmt10+ years in pharma/clinical industry; leading QA, GMP/GCP, audits; bilingual Spanish preferred; FDA/Regulatory inspections experience.
GCP, FDA CFR 21 Part 11, CAPA, QMS, eQMS, Clinical Trial Management Systems, MS Word, MS Excel
2mo
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Sr. QA Specialist, Operations
Plantation, Florida, United States
OnsiteFull Time
5+ YOESenior QA on-floor role ensuring GMP compliance; 5-8 years GMP, cGMP, aseptic manufacturing, data integrity; high school diploma required; associate or bachelor's preferred.
GMP systems, Aseptic manufacturing, CAPA, SOPs, NetSuite, Documentation control, Batch records review
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