168 fda jobs at 65 companies in Stafford, TX
3mo
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Senior Supplier Quality Engineer
Houston, Texas, United States
$110k-$120k/yr OnsiteFull Time
8+ YOEBachelor's degree in engineering; 8+ years quality/manufacturing engineering experience; regulated FDA medical device environment preferred; strong quality and project management skills.
Quality Management System (QMS), ISO 13485, MDSAP, FDA regulations
6d
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Order Processing & Fulfillment Technician 503B (2nd shift)
Houston, Texas, United States
OnsiteFull Time
1+ YOERequires 1+ year in pharmacy operations, order fulfillment, or inventory management, a high school diploma, ERP software proficiency, and knowledge of cGMP, GDP, and FDA regulations.
ERP, AI, cGMP, GDP, FDA
3d
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Patient Access Liaison
Houston or Dallas or Austin or San Antonio or Texas or Missouri or Kansas or Arkansas or Oklahoma
FieldFull Time
5+ YOEBachelor's degree, 5+ years in patient services, field reimbursement, biopharma sales, or account management, including 1+ year supporting patients; rare disease, HIPAA, and FDA knowledge required.
Patient Journey Navigator (PJN), HIPAA, FDA
2mo
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Center Director 1
Pasadena, Texas, United States
OnsiteFull Time
Leadership role overseeing donation center operations, regulatory compliance (FDA/OSHA/CLIA/GMP), quality and safety programs, staff management, training, and achievement of production and financial targets; bachelor’s preferred.
FDA, OSHA, CLIA, GMP, CAPA
1d
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OR1 Global Product Manager
Stafford, Texas, United States
$115k-$156k/yr HybridFull Time
8+ YOEBachelor's degree and 8+ years of product management or related experience, preferably in medical devices. Requires product lifecycle, regulated medical technology, IT infrastructure, networking, FDA/MDR, requirements management, and cross-functional collaboration skills.
IT infrastructure, networking, distributed computing, FDA, MDR, Agile, Scrum, SAP, MS Project
1mo
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Associate Quality Engineer
Houston, Texas, United States
$51k-$101k/yr OnsiteFull Time
0+ YOEBachelor's in engineering or technical field (or equivalent), 0–2+ years engineering experience, knowledge of FDA/GMP/ISO standards, experience with quality tools, statistical/data analysis, Six Sigma/Lean experience preferred, strong communication and project skills.
FDA, GMP, ISO 13485, ISO 14971, Six Sigma, Lean Manufacturing, QMS, EMS
1mo
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Associate Quality Engineer
Houston, Texas, United States
$51k-$101k/yr OnsiteFull Time
0+ YOEBachelor's in engineering or technical field (or equivalent), 0-2+ years engineering experience, knowledge of FDA/GMP/ISO 13485 & 14971, use of quality tools, Six Sigma/Lean experience preferred, strong communication and statistical/data analysis skills.
FDA, GMP, ISO 13485, ISO 14971, Six Sigma, Lean Manufacturing, QMS, EMS, CAPA
1w
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Director, Clinical Research Regulatory Affairs
Houston, Texas, United States
$147k-$220k/yr RemoteFull Time
8+ YOE2+ MgmtBachelor's in life sciences/pharmacy/medicine required, Master’s preferred; 8+ years regulatory affairs experience with FDA submissions, 2+ years lead project management, RAC preferred, strong FDA/ICH/GCP knowledge.
1mo
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Regulatory Compliance Specialist - Transplant Center
Houston, Texas, United States
OnsiteFull Time
2+ YOEBachelor's degree, 2 years clinical research or regulatory compliance experience in academic/FDA-regulated settings; knowledge of IRB/FDA/GCP, strong communication, data entry, and process improvement skills; Excel/Word/PowerPoint proficiency.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint
4w
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Director, Clinical Research Regulatory Affairs in United States, Texas, Houston, Houston (TX Med Ctr)
Houston, Texas, United States
$147k-$220k/yr RemoteFull Time
8+ YOE2+ MgmtBachelor's required, Master's preferred; 8+ years regulatory affairs experience with FDA submissions and oncology research; 2+ years lead project management; IND/IDE experience preferred; RAC preferred; strong FDA, ICH/GCP knowledge.
4w
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Tooling Technician I
Rosenberg, Texas, United States
OnsiteFull Time
Inspect, clean, polish, measure, and maintain tablet and capsule tooling to meet FDA requirements using precision measuring tools.
Calipers, micrometer, Vernier caliper, feeler gauges, Dremel tool, bench buffer/grinder wheel, dial indicator, die bore gauge, go no-go gauges
1mo
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Biolife - Licensed Practical Nurse (LPN)
Humble, Texas, United States
$24-$33/hr OnsiteFull Time
2+ YOECurrent LPN/LVN license in Texas, CPR and AED certification, basic IV therapy, FDA BioLife training, 2 years clinical experience.
4w
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Quality Assurance Specialist
Houston, Texas, United States
OnsiteFull Time
5+ YOEBachelors in science required. Experience with GMP, investigations, CAPA, audits, quality metrics, and MasterControl; 5+ years conducting investigations in FDA-regulated environments preferred.
MasterControl, eQMS
2mo
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Clinical Research Site Director
Boston or Houston
OnsiteFull Time
8+ YOE5+ Mgmt8+ years clinical research experience; 5+ years managing multiple trials and teams; strong knowledge of FDA regulations, ICH-GCP, and site operations.
EDC, IVRS, Electronic Data Capture, SOPs
4w
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MANUFACTURING ENGINEER
Rosenberg, Texas, United States
$80k-$100k/yr OnsiteFull Time
5+ YOEBachelor's degree in engineering,5+ years engineering experience in pharmaceutical or regulated manufacturing,cGMP and FDA knowledge,equipment qualification and process validation experience,SAP experience.
SAP
4w
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CMA, LVN or RN - Kingwood
Kingwood, Texas, United States
OnsiteFull Time
1+ YOECMA certification or LVN or RN license valid in Texas, 1–2 years medical experience, knowledge of OSHA/FDA/HIPAA, skilled charting, and strong communication.
1mo
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Process Engineer
Houston, Texas, United States
OnsiteFull Time
5+ YOEBachelor's in Chemical Engineering, over 5 years process engineering experience in cosmetics, proficiency with MS Office, knowledge of GMP/FDA, strong analytical and communication skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
2w
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Study Manager I (4011)
Sugar Land, Texas, United States
OnsiteFull Time
5+ YOE5+ years clinical research experience required, knowledge of FDA and ICH-GCP, completion of study trainings, strong communication, and ability to manage site compliance and enrollment.
2mo
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Senior Process Engineer
Stafford, Texas, United States
OnsiteFull Time
7+ YOE7+ years of process engineering in regulated manufacturing; medical device experience preferred; strong FDA QSR/ISO 13485 knowledge; root cause analysis experience.
3w
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Logistics - Logistics Coordinator
Houston, Texas, United States
OnsiteFull Time
2+ YOEPreferred associate degree, minimum ~2 years logistics/transportation experience, knowledge of import/export documentation, FDA regulations, strong communication, Excel and ERP/TMS familiarity.
Microsoft Office, Microsoft Excel, ERP, transportation management systems (TMS)