FDA Jobs in Dallas, TX

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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

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

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

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

Business Quality Assurance (BQA)

Activesoft, Inc.

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)

PTC Arena Consultant

Teknikoz

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

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

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

Food Quality Assurance Supervisor

LSG Sky Chefs

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

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

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

Devops Engineer

Beacon Systems, Inc

Dallas, Texas, USA

Contract

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position: Devops Engineer Location: Hybrid - Dallas, TX Duration: 12 Months plus Essential exp

Software Engineer - C#

Beacon Systems, Inc

Dallas, Texas, USA

Contract

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position: Software Engineer Duration: 12 Months plus Location: Hybrid - Dallas, TX Job Descrip

Software Engineer - W2 (C#, Python, Typescript)

Beacon Systems, Inc

Dallas, Texas, USA

Contract

Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. We are looking for a Software Engineer at Hybrid - Dallas, TX Request you to make sure your updated Resume highlights al

Lead Mechanical Design Engineer

Catapult Solutions Group

Plano, Texas, USA

Contract

Lead Mechanical Design Engineer for Automation Systems Department: Engineering Location: Plano, TX - Onsite Role Type: Contract About Our Client Our client operates a cutting-edge innovation lab focused on developing automated solutions for the food service industry. Located within a major corporate headquarters in Plano, TX, they are dedicated to advancing automation technology that enhances efficiency, safety, and reliability in food preparation and processing environments. The company values

OpenStack Platform Engineer

Beacon Systems, Inc

Dallas, Texas, USA

Contract

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. JOB DESCRIPTION: As a Compute Engineer, you'll be at the forefront of delivering our cutting-e

Quality Assurance Manager

Treehouse Foods

Carrollton, Texas, USA

Full-time

Employee Type: Full time Location: TX Carrollton Job Type: Quality Job Posting Title: Quality Assurance Manager About Us : TreeHouse Foods (NYSE: THS) is a leading manufacturer of private label packaged foods and beverages, operating a network of over 20 production facilities and several corporate offices across the United States and Canada. At TreeHouse Foods, our commitment to excellence extends beyond our products and revolves around our people. We are investing in talent and creating a pe

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

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

Drug Safety Scientist

Sunrise Systems, Inc.

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