1mo
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Director, Quality & Regulatory- Mergers & Acquisitions (M&A)
Colorado Springs or Nashville or Bothell or Gainesville or San Diego or Plymouth or Cambridge
$162k-$258k/yr HybridFull Time
15+ YOE15+ years in FDA-regulated medical device environments, leadership in quality/regulatory and M&A, Bachelor's required (Master's/MBA preferred), knowledge of FDA/ISO/EU MDR, QMS and KPI-driven governance.
QMS, FDA, ISO 13485, ISO 14971, EU MDR, TSLA, KPI
2mo
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Daytona Clinical Research Positions (Pooling)
Daytona Beach, Florida, United States
OnsiteFull Time
Bachelor's degree; Master’s preferred; experience in clinical trials; knowledge of GCP/FDA guidelines; bilingual Spanish/English desirable; strong leadership and mentoring skills.
GCP, FDA regulations, clinical trial management systems, source documentation, phlebotomy, ECG
2w
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Quality Control Auditor
Sanford, Florida, United States
$17-$20/hr OnsiteFull Time
Knowledge of QMS (ISO, FDA, BSI) and printing quality processes preferred; strong attention to detail, Microsoft Office proficiency, ability to lift 75 lbs, and strong communication skills.
ISO, FDA, BSI, Plant Test Methods (PTM), Microsoft Office
3w
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Lab Technician, Overnight, Fresh Kitchen - Deerfield
Deerfield Beach, Florida, United States
$21-$29/hr OnsiteFull Time
Perform quality control and inspections, collect and process samples, maintain HACCP and FDA records, follow GMPs, lift >25 lbs frequently, work nights/weekends/holidays, and perform data entry and documentation.
Microsoft Word, Microsoft Outlook, Microsoft Access, Microsoft Excel, HACCP, FDA
2mo
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Sr. Process Engineer - Tampa, FL (Relocation Available)
Tampa, Florida, United States
$115k-$150k/yr OnsiteFull Time
7+ YOEBachelor's in chemical, mechanical, or process engineering; 7+ years; turnkey skid/tank systems; sanitary design (CIP/SIP); FDA/cGMP/3-A/ASME BPE knowledge; leadership and client-facing skills; relocation to Tampa.
CIP, SIP, PFD, P&ID, FDA, cGMP, ASME BPE, Engineering calculations
2mo
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Compliance Officer
Orlando or United States
RemoteContract
3+ YOE3+ years regulatory compliance experience with medical devices or complex hardware; knowledge of FDA/CE/ISO pathways, SOC 2 programme experience, functional safety standards, technical writing, and ability to work remotely with senior leadership.
FDA, CE, ISO 13485, ISO 14971, IEC 62443, ISO 26262, IEC 60601, UL 3100, ANSI/RIA R15.08, SOC 2, ETL
1mo
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Sr. Cost Optimization Project Manager
Gainesville, Florida, United States
OnsiteFull Time
6+ YOEBachelor's in engineering/operations/supply chain required; 6+ years in medical device or regulated manufacturing; 2+ years leading cross-functional programs; proven cost reduction, value engineering, and regulatory (ISO/FDA/Design Controls) experience.
Lean, Six Sigma, Value Engineering, Design-to-Cost, Design Controls, Quality Management System (QMS), ISO, FDA
1mo
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Sr. Cost Optimization Project Manager
Gainesville, Florida, United States
OnsiteFull Time
6+ YOEBachelor's in engineering/operations/supply chain, 6+ years in medical device or regulated manufacturing, 2+ years leading cross-functional programs, experience driving cost-out/value engineering, knowledge of Design Controls, QMS, ISO, and FDA requirements.
Design Controls, Quality Management System (QMS), Lean, Six Sigma, ISO standards, FDA regulations, BOM
2mo
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Computer Software Assurance Supervisor (34284)
Jacksonville, Florida, United States
RemoteFull Time
5+ YOEBachelor’s degree in Engineering, Life Sciences, Computer Science, or related field; 5+ years in software validation/CSA/CSV in medical devices; proven cross-functional project leadership in regulated environments; knowledge of FDA/ISO (13485 preferred) and CSA methodologies.
CSA, FDA regulations, ISO 13485, Quality Management System (QMS), Risk assessment, Test protocols, Traceability matrices, Change control, Documentation management
1mo
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SPQA I
Largo, Florida, United States
OnsiteFull Time
1+ YOEMinimum 1 year in an FDA-regulated pharmaceutical or medical device environment, high school diploma, working knowledge of FDA/cGMP, ability to lift 25 lb, use measuring devices, scanners, and perform documentation per GDP.
2mo
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Clinical Research Coordinator
Lake Worth, Florida, United States
OnsiteFull Time
1+ YOEHigh school diploma; 1 year CRC or 2 years Research Assistant; knowledge of FDA/GCP; bilingual English/Spanish preferred
2mo
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QC Microbiologist I
Tamarac, Florida, United States
OnsiteFull Time
1+ YOEBachelor’s in microbiology; 1-2 years lab exp; Master’s in microbiology with 1-2 years exp; knowledge of FDA, cGMPs, and SOPs.
GMP, USP, SOPs, biomonitoring, microbial testing
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
4d
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Phlebotomist 3
St. Petersburg, Florida, United States
OnsiteFull Time
0.25+ YOEPerform venipuncture and plasmapheresis, follow FDA/OSHA/CLIA/GMP procedures, document records, operate automated plasmapheresis equipment, and train/mentor staff.
automated plasmapheresis machine
1w
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Production Supervisor - 2nd Shift and 3rd Shift (m/f/d)
Miami, Florida, United States
$60k-$65k/yr OnsiteFull Time
Supervisory manufacturing experience, cGMP/FDA/CFR knowledge, production scheduling, mechanical aptitude, documentation and quality control, leadership and shift‑management skills.
2mo
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Senior Global Procurement Lead
Rochester or Pompano Beach or Athens
$102k-$133k/yr OnsiteFull Time
8+ YOEBachelor’s in Business/Engineering; 8-10 years procurement in regulated environment; ISO/FDA experience; strong leadership; packaging procurement experience preferred.
Microsoft Office, Power BI
2mo
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Quality Assurance Manager (Pharmaceutical)
Miami, Florida, United States
OnsiteFull Time
5+ YOE1+ MgmtQA leadership with GMP, FDA, ISO; 5+ years in QA/QMS; cross-border LATAM-USA operations; bilingual English/Spanish preferred.
Microsoft Office, QMS platforms, Quality tools
2mo
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Vice President, Quality
Miami, Florida, United States
OnsiteFull Time
15+ YOELead QA/QC, develop QMS, ensure regulatory compliance (FDA, GMP, GCP, ISO), manage audits, build high-performance team.
QMS, GMP, GCP, ISO Standards
1w
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Assistant Plasma Center Manager
Port Orange, Florida, United States
OnsiteFull Time
1+ MgmtBachelor's preferred, minimum 1 year supervisory experience, knowledge of FDA/CLIA/cGMP, proficiency in Microsoft Office, strong leadership and organizational skills.
Microsoft Office
2w
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Clinical Research Coordinator II (669697)
St. Petersburg, Florida, United States
$28-$45/hr OnsiteFull Time
Bachelor's in health/biological/nursing/public health, clinical research coordination experience, knowledge of GCP/FDA/IRB, strong organization and communication skills.
EPIC, OnCore, REDCap, Rave, Veeva Vault
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