fda Jobs in rockville, md

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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

Business Analyst

NTT DATA Americas, Inc

Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 328701 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE) Job Description: Experience Level: 7 9 years of relevant experience Role Overview: The Business Analyst (BA) w

Proposal Writer / Proposal Development Specialist

ExpediteInfoTech, Inc.

Rockville, Maryland, USA

Full-time, Contract

Position Summary : The Proposal Writer / Proposal Development Specialist supports the proposal and business development teams in growth activities. This position involves conducting research, proposal writing and content development. Experience in creating compliant proposal responses to Federal solicitations is required. Candidates should have experience collaborating with various stakeholders to develop win themes and value propositions and providing essential proposal development process su

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

Technical Proposal Solutions Architect

ExpediteInfoTech, Inc.

Rockville, Maryland, USA

Full-time, Contract

Summary: As the Technical Proposal Solutions Architect for ExpediteInfoTech, Inc. (EIT), you will lead overall technical solutions for RFIs, RFPs, RFXs, SSNs, including for IDIQs, BPAs, GWACs, Task Order contracts and technical marketing material including white papers. Providing technical strategies, solutions, and forward-looking advisory services are just a few of the exciting responsibilities of this position.The successful candidate will possess a broad base of core technical knowledge and

PTC Arena Consultant

Teknikoz

Remote

Contract, Third Party

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

Lead Engineer MES OpCenter

New York Technology Partners

Remote

Contract

Job Title: Lead Engineer MES OpCenter Location: 100% Remote Experience: 12+ Years JD: Lead Engineer MES OpCenter The Lead Engineer will lead a team of technical resources to design, develop, configure and test MES (Manufacturing Execution Systems) solutions. They will be directly responsibility for leading resources contracted via a third-party and through other J&J organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. The Lead Engineer will b

Artificial Intelligence Solutions Architect

Arena Technical Resources

Washington, District of Columbia, USA

Full-time

Job Title: Artificial Intelligence Solutions Architect Job Location: Rockville, MD Remote (candidate will need to be in the DMV area) Eligibility/Clearance: ship Required. Must be able to obtain a clearance, this position supports a government contract Job Description: We are seeking a skilled AI Solutions Architect to join our expanding team supporting the U.S. Food and Drug Administration (FDA). In this mission-critical role, you will design, implement, and optimize AI and machine learning

Senior Appian Developer

General Dynamics Information Technology

Gaithersburg, Maryland, USA

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Engineering Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: None Experience: 5 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fill multiple-level Appian Developer roles on

Senior Appian Developer

General Dynamics

Gaithersburg, Maryland, USA

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Engineering Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: None Experience: 5 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fill multiple-level Appian Developer roles on

Appian Developer

General Dynamics

Gaithersburg, Maryland, USA

Full-time

Type of Requisition: Regular Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Engineering Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: None Experience: 4 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fill multiple-level Appian Developer roles on a

Sr Validation Engineer

Katalyst Healthcares and Lifesciences

Columbia, Maryland, USA

Full-time

Responsibilities: Responsible for preparing, executing commissioning and qualification documents for a variety of utilities, facility, and process equipment. Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment. Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team. Excellent leadership skills include the ability to simultaneously organize, and successfully execute

Remote Senior Appian Developer

Computer Merchant, Ltd., The

Remote or Rockville, Maryland, USA

Full-time

JOB TITLE: Senior Appian Developer JOB LOCATION: Remote WAGE RANGE*: $75HR TO $80HR JOB NUMBER: 25-02929 REQUIRED EXPERIENCE: MUST OBTAIN A PUBLIC TRUST Skills: Appian BPM, Application Design, Software Development Experience: 10 + years of related experience JOB DESCRIPTION The Food and Drug Administration (FDA) is the federal agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devic

ServiceNow Developer / Application Developer

Beacon Systems, Inc

Arlington, Virginia, 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 Services. We have a vast portfolio of clients across the country. 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: ServiceNow Developer / Appli

Salesforce Architect (Remote DMV Area)

ICF

Remote or Reston, Virginia, USA

Full-time

*We are open to supporting 100% remote work anywhere within the US. Preferred candidate will sit in US, working Eastern Standard Time. May be required to attend quarterly meetings in Metro DMV area* ICF's Digital Modernization Division is a rapidly growing, entrepreneurial, technology department, seeking a Salesforce Architect. Our services focus on enabling agency mission and business transformation using industry-leading low-code platforms, mobile applications, robotics process automation and

Regional Sales Manager - Northeast US

GEA

Columbia, Maryland, USA

Full-time

GEA Group, founded in Germany in 1881, is a global leader in engineering solutions, serving industries such as food and beverage, pharma, dairy, and more. With over 18,000 employees worldwide and a strong U.S. presence since 1929, GEA combines the heritage of a well-established company with the innovation of a forward-thinking industry leader. At GEA, we're not just building equipment, we're building lasting careers with an average employee tenure range from 5 to over 11+ years, reflecting the s

Mechanical Engineer

Apex Systems

Sterling, Virginia, USA

Full-time

Job#: 2067560 Job Description: Position Title: Mechanical Engineer Type: Direct Hire/Permanent (not contract) Location: Sterling, VA (100% onsite Monday-Friday, no remote work) Position Overview: We are currently seeking a Mechanical Engineer who will be responsible for assisting in the mechanical design and building of medical devices. Our company designs, manufactures and sells robotic systems that are used by patients in hospitals around the world. The position we are seeking to fill will

Data Analyst

Trigent Solutions

Remote

Full-time

Title: Data Analyst Location: 100% Remote Client: FDA Duration: Full Time Permanent. Job Description: We are seeking a detail-oriented Data Analyst with experience in data visualization and statistical analysis to support our analytics and reporting initiatives. The ideal candidate will have hands-on expertise with AWS QuickSight, Posit (formerly RStudio), R, and SQL, and be comfortable working with large datasets. Key Responsibilities: Design, build, and maintain dashboards and reports using AW

Regulatory Affairs Manager

LMI Government Consulting (Logistics Management In

Frederick, Maryland, USA

Contract

Overview LMI is seeking an experienced Regulatory Affairs Manager to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in Frederick, MD location. Will serve as lead auditor for quality audits (GMP & GLP) of developing and manufacturing investigational countermeasures for MCS. This position can be performed hybrid/remotely with onsite requirements 1 day per week. This position requires the ability to pass a T1/NACI securit

SAP GTS Consultant

Altitude Technology Solutions Inc

Remote

Contract, Third Party

Hello,Greetings,Hope you are safe & healthy. My name is Kundan Mishra. I am a Technical Recruiter with Altitude Technology Solutions (ATS) INC.The purpose of this email is to serve as an invitation to discuss the opportunity below with our customer that I think you or your candidate would be a great fit for. Role: SAP S/4 GTS ConsultantLocation: 100% Remote Must Have:SAP GTS Hands-on implementation experience with least 2 full life-cycle implementations including GTS E4HExpert knowledge in Impor