FDA Jobs in Texas

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W2 only Software Quality Assurance Consultant - EST/CST Only - regulatory affairs Medical Devices, software development life cycle risk management and configuration management FDA

APN Software Services, Inc

•

Remote

Contract

Please contact Abdul on "" OR email me at "" Job Responsibilities: Provides guidance and quality oversight of the development, testing strategy, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements. 2. Participates as an integral team member in various phases of the Software Development Life Cycle (SDLC), providing timely and meaningful feedback for project documentation including software requirements, design, test pl
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Posted 7 days ago | Updated 2 days ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

•

Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
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Posted 60+ days ago | Updated moments ago

JD Edwards Functional Analyst ? Full-Time (Hybrid)

iSphere

•

Houston, Texas, USA

Full-time

Job Title: Oracle JD Edwards Functional Analyst - Full-Time (Hybrid)Location: Houston, TX (Hybrid - 60% onsite, 40% remote) after onboard and supervisor approval. Job Type: Full-Time / Direct HireIndustry: Energy, Manufacturing, Distribution, Finance, ERP Systems About the Role:Our Houston-based client is seeking a skilled Oracle JD Edwards (JDE) Functional Support Analyst responsible for gathering requirements, configuring the ERP (JD Edwards) software performing analysis/design, development, t
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Posted 33 days ago | Updated moments ago

Medical Devices Software Program Manager (REMOTE/WEST COAST CANDIDATES)

Amerit Consulting

•

Remote

Contract

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an Medical Devices Software Program Manager NOTE: THIS IS REMOTE ROLE & ONLY W2 CANDIDATES (NO C2C/1099) Candidate must be authorized to work in USA without requiring sponsorship Position: Medical Devices Software Program Manager(Job Id - # CFNJP00051124) Location: San Diego CA 92130 (Remote) Duration: 6 months + Contract to
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Posted 10 days ago | Updated 1 day ago

Business Quality Assurance (BQA)

Activesoft, Inc.

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Remote

Contract

Mandatory Skills & Qualifications: Strong knowledge in GMP, cGMP, and regulatory standards:21 CFR Part 1121 CFR Part 21021 CFR Part 211ICH Q7Experience facing FDA audits at pharmaceutical manufacturing sitesHands-on experience with manufacturing processes, CAPAs, deviations, etc.Lead Auditor or any other compliance certifications (preferred)
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Posted 26 days ago | Updated 1 day ago

Technical Writer

Horizontal Talent

•

Irving, Texas, USA

Contract

We are seeking a talented Technical Writer to join our dynamic team. This role offers the opportunity to create clear and concise documentation that supports our innovative projects in the healthcare industry. ResponsibilitiesDevelop and maintain technical documentation, including forms, procedures, and regulatory documents.Translate complex technical information into user-friendly content for diverse audiences.Collaborate with cross-functional teams to gather information and ensure accuracy in
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Posted 4 days ago | Updated 1 day ago

PTC Arena Consultant

Teknikoz

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Remote

Third Party, Contract

Key Responsibilities:Lead the technical delivery of PLM solutions using PTC Windchill and Arena PLM/QMS. Guide a team of engineers and consultants across India and the USA. Configure, customize, and maintain PLM modules such as BOM, Change Management, Document Control, and Lifecycle Management. Collaborate with business stakeholders to gather requirements and design scalable PLM workflows. Oversee PLM/ERP integrations and ensure data integrity across systems. Provide mentorship, code reviews, an
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Posted 2 days ago | Updated 2 days ago

Production Training and Development Manager

Accroid Inc

•

San Antonio, Texas, USA

Full-time, Third Party

Our client, an exciting and growing Bio Sciences firm, is searching for a Production Training and Development Specialist. The Training and development specialist will be responsible for the strategic development, implementation, and oversight of the organization's training program in accordance with FDA 21 CFR 1271, AATB standards, and internal policies governing the recovery, processing, and distribution of human tissue for transplantation. This position ensures that all personnel are adequatel
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Posted 22 days ago

Engineering Documentation Expert

Katalyst Healthcares and Lifesciences

•

Fort Worth, Texas, USA

Full-time

Responsibilities: Develop comprehensive technical documentation, including user manuals, installation guides, labeling materials, and regulatory documentation for ophthalmic devices. Work closely with engineering, regulatory, and quality teams to ensure all documentation meets industry standards and regulatory requirements. Interpret engineering drawings and specifications to create detailed build and qualification procedures for complex ophthalmic systems. Collaborate with R&D and manufacturing
Posted 24 days ago | Updated moments ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

•

Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract , remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Acti
Posted 22 hours ago | Updated 10 hours ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

•

Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract, remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Active
Posted 1 day ago | Updated 10 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Dallas, Texas, USA

Full-time

Responsibilities: Develop, execute, and document test method validation protocols to ensure accuracy, precision, and reliability of testing procedures. Lead validation activities for new or existing test methods, ensuring compliance with regulatory standards (e.g., FDA, ISO). Review and assess the performance of test methods, providing recommendations for improvements as needed. Perform data analysis and generate reports for test method validation studies, ensuring all required documentation is
Posted 24 days ago | Updated moments ago

Warehouse

LSI Staffing

•

Dallas, Texas, USA

Full-time

**Now Hiring in the Garland Area!** **Positions Available:** 1. **Janitorial** - **Hours:** 2nd Shift (1:30 PM - 10:00 PM), Monday - Friday, plus some weekends - **Pay Rate:** $18.00 per hour 2. **Production** - **Hours:** 1st Shift (6:00 AM - 2:30 PM), Monday - Friday, plus some weekends - **Pay Rate:** $16.50 per hour 3. **Sanitation** - **Hours:** 1st Shift (6:00 AM - 2:30 PM), Monday - Friday, plus some weekends - **Pay Rate:** $17.00 per hour **Job Openings:** 1 to 10 positions available
Posted 2 days ago | Updated 8 hours ago

Drug Safety Scientist

Sunrise Systems, Inc.

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Remote

Contract

Job Title Drug Safety Scientist Job ID: 25-08470 Location: 100% Remote (Candidates should be in EST only) Duration: 12 months on W2 Contract Summary: Seeking an experienced Drug Safety Scientist with 5+ years in pharmacovigilance to support regulatory safety reporting and risk management. Must hold a Bachelor's/Master s in Pharmacy, Biotechnology, or Chemistry. Key Responsibilities: Author safety reports (DSUR, PBRER, PADER)Support signal detection and safety data evaluationConduct literature
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Posted 5 days ago | Updated 1 day ago

Food Quality Assurance Supervisor

LSG Sky Chefs

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Dallas, Texas, USA

Full-time

Job Title: Food Quality Assurance Supervisor Job Location: Dallas-USA-75261 Work Location Type: On-Site Salary Range: $68,779.42 - 68,779.42 About us LSG Sky Chefs is one of the world's largest airline catering and hospitality providers, known for its outstanding reputation and dynamic approach in the industry. Voted "Airline Caterer of the Year in North America" for 2023 and 2024, we are committed to excellence and innovation, driven by the dedication and expertise of our talented employees. Ou
Posted 1 day ago

Validation Engineer NPI

Katalyst Healthcares and Lifesciences

•

Irving, Texas, USA

Full-time

Roles and responsibilities: NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA. 3+ years of experience & demonstrated proficiency in New Product Introduction, Windchill PLM & providing ongoing technical support is preferred. Under limited supervision, performs and documents moderately complex technical functions relating to test, quality control, Client-out, fabrication, modification, and assembly of mechanical
Posted 24 days ago | Updated moments ago

Remote Senior QA Test Manger/QA Leader with Strong Healthcare Domain

Infinite Computer Solutions (ICS)

•

Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Descriptions : We are looking for an experienced Senior QA Healthcare Manager/QA Leader to lead the quality assurance team in ensuring the reliability, security, and compliance of healthcare applications. The ideal candidate should have a strong background in healthcare software testing, regulatory compliance (HIPAA, CMS, FDA), test automation, and team leadership. Key Responsibilities: Lead and manage the QA t
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Posted 4 days ago

Senior Expert Physicist

Spar Information Systems

•

US

Contract, Third Party

Looking for a Senior-Level Expert-preferably a scientist or physicist-with hands-on experience designing, developing, and troubleshooting magnetic tracking systems, especially in medical device or similar precision environments. Key Requirements: Domain-Specific Expertise Must have direct experience building and shipping magnetic tracking solutions-ideally used in catheter navigation, cardiac, gastrointestinal, or surgical tracking systems. Should be deeply familiar with electromagnetic field be
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Posted 8 days ago | Updated 3 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 24 days ago | Updated moments ago

Software Quality Engineer

Katalyst Healthcares and Lifesciences

•

Irving, Texas, USA

Full-time

Responsibilities: Review and Approval of software lifecycle (SLC) Deliverables for Regulated applications; Risk Classifications, Requirements, Config/Design Specs, IQ, OQ, PQ, Trace Matrix, Summary Reports etc. Collaborate with the cross-functional teams to build compliance capabilities to assure the quality of the deliverables and ensure the business needs are met. Review of CAPAs, Change Controls and Defects for GxP applications. Working with Global teams and providing audit support. Work
Posted 24 days ago | Updated moments ago