FDA Jobs

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Product Security Engineer

Vankay Systems

•

Danvers, Massachusetts, USA

Contract

Role: Product Security Engineer Hiring Mode: Contract (TP) Location: Danvers, MA-01923 [On-site] Skills Matrix Skill Last Used Experience in Years/month Rating (10 points) 1 = newbie 10 = expert Hands on Exp. Yes/No Security risk management techniques Regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR) Pre-market product development activities Medical devices FDA Job Description: 5+ years industry experience in Information Security.Wor
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Posted 6 days ago

Product Security Engineer (Medical Device)

Zenox Global, LLC

•

Danvers, Massachusetts, USA

Contract, Third Party

Product Security Engineer Danvers, MA ( day 1 onsite) 12+ Months Contract Job description 5+ years industry experience in Information Security.Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR).Experience with security risk management techniques.Demonstrated organizational skills, attention to detail, the ability to handle multiple assignments simultaneously in a timely manner and be able to meet assigned deadlines
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Posted 12 hours ago | Updated 12 hours ago

MES Engineer

People Force Consulting Inc

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Johns Creek, Georgia, USA

Contract, Third Party

MES Engineer Johns Creek, GA Tentative duartion - 6 - 12 months Contract As an MES Engineer, you will be part of a team responsible for the implementation, support, and optimization of our Manufacturing Execution System (MES). You will work closely with cross-functional teams to ensure the MES aligns with production goals, improves efficiency, and supports our commitment to quality and operational excellence. Key Responsibilities: Provide technical support and training to manufacturing personn
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Posted 20 days ago | Updated 20 hours ago

Systems Engineer - Software Integration and Testing

Tranzeal, Inc.

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Tucson, Arizona, USA

Contract

Systems Engineer (Software Integration and Testing) Onsite Position - Tucson AZ Advanced Knowledge: Advanced understanding of software engineering, electronics, electro-mechanical systems, information technology, and basic chemistry. This role focused on a Systems Engineer specializing in software integration and testing within the exciting and innovative field of cancer diagnostics at Client Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experi
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Posted 12 days ago

HSE Specialist - Onsite

VIVA USA INC

•

Hazelwood, Missouri, USA

Contract

Title: HSE Specialist - Onsite Mandatory skills: Health, Safety, Environmental, CSR, OSHA, EPA, NFPA, HSE Management System, HSE support, HSE process, HSE procedure, HSE Metrics, manufacturing, R&D, FDA, ISO, Medical Devices, Diagnostics, cGMP, HSE goals, Job Safety Analyses, Risk assessments, Environmental Assessments, Incident Reporting System, HSE inspections, legal requirements, process improvement, quality procedure, quality standards, continuous improvement, documentation requirements, de
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Posted 1 day ago

Biomedical Technician - Onsite

VIVA USA INC

•

Madison, Wisconsin, USA

Contract

Title: Biomedical Technician - Onsite Mandatory skills: medical imaging, laboratory equipment, electrical circuits, mechanical assemblies, control systems, soldering PCB components, replacing PCB components, diagnostic tools, multimeters, oscilloscopes, hand tools, precision assembly, interpret technical drawings, schematics, manuals, Healthcare equipment, medical imaging systems, X-ray systems, X-ray machines, bone densitometers, lab equipment, laboratory instruments, radiation safety, medical
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Posted 7 days ago

Regulatory Engineer

iTek People, Inc.

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Wisconsin, USA

Contract, Third Party

Role: Regulatory Engineer Location: Milwaukee, WI Experience: 6 Job Description: Responsibilities Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations. Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality
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Posted 19 days ago

Project Manager Business Professional II

Pyramid Consulting, Inc.

•

Round Lake, Illinois, USA

Contract

Immediate need for a talented Project Manager Business Professional II. This is a 06+months contract opportunity with long-term potential and is located in Round Lake, IL (Hybrid). Please review the job description below and contact me ASAP if you are interested. Job ID: 25-67558 Pay Range: $70 - $75/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: The work w
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Posted 14 days ago

Document Control Associate

Aditi Consulting

•

Manassas, Virginia, USA

Contract

Payrate: $30.00 - $32.00/hr. Summary: The creation and maintenance of the Quality System documentation. Communicate any deviations to management. Assist the Quality Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards. Job Duties: Create, revise, and maintain all documentation related to the Quality System using technical writing best practices, ensuring proper formatting, numbering, and document control. Issue batch recor
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Posted 14 hours ago | Updated 7 hours ago

Technical Writer

STM Consulting, Inc.

•

Mesa, Arizona, USA

Contract

Technical Writer Hybrid 2 to 3 days a week in Mesa, AZ Contract: 6 Months Profile: Bachelor's Degree 3+ years' experience in Technical Writing for Medical devices Strong understanding of ISO 13485, ISO 14971, FDA QSR - 21 CFR Part 820 Good understanding of regulatory compliance for medical devices Ensure all documents conform to FDA requirements for GMP/QSR and ISO13485 Professional experience writing technical documentation for both hardware and software in a FDA regulated environment Abili
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Posted 44 days ago | Updated 28 days ago

JD Edwards ERP Analyst

EDI Specialists, Inc.

•

Houston, Texas, USA

Full-time

The JDE Analyst designs, develops, and supports JD Edwards EnterpriseOne 9.2 applications. This role collaborates with business and IT teams to deliver effective solutions, troubleshoot issues, and optimize system performance. < data-end="313" data-start="282"> Key Responsibilities Design, develop, and document JDE solutions based on business needs. Build, test, and implement custom solutions using JDE development tools. Support and enhance integrations between JDE and other applications. Troub
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Posted 29 days ago | Updated 7 hours ago

Data Architect (Medicare & Pharmaceutical Focus)

ConglomerateIT

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Newark, New Jersey, USA

Contract

Job Title: Data Architect (Medicare & Pharmaceutical Focus) Tax Term: 1099 , W2 Only Location: Onsite (NJ/PA preferred; open to strong remote candidates working US Eastern hours) Employment Type: Contract About us Conglomerate IT is a certified and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains. Visit us at Our mission is to establish global cross culture human connections that further the careers of our employee
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Posted 16 days ago | Updated 12 hours ago

IT Program Manager

AP Ventures

•

Columbia, Maryland, USA

Contract

Title: IT Program Manager - FDA Location: Hybrid in Columbia, MD Company Background A P Ventures, LLC (APV) is an innovative Woman-Owned Small Business (WOSB) providing services to Government customers at the federal and state levels in three key focus areas: High-End IT Consulting, Emerging Technology and Training Solutions, and Human Capital Services. Established in 2007, APV has completed 70+ prime contracts and currently oversees 25+ task orders, consistently achieving high client satisfact
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Posted 16 days ago | Updated 7 days ago

SAP Plant Maintenance (SAP PM)

IT Resonance Inc.

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Remote

Contract, Third Party

SAP Plant Maintenance (SAP PM) 12 months Remote with travel to onsite (Chicago IL) Must have food & beverage manufacturing or consumer packaged goods industry experience Solid/Strong comm skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards Stephen DJA stephen at itresonance dot com
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Posted 13 days ago

Regulatory affairs - CMC Manager

American IT Systems

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Remote

Contract

PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries.Prepare a
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Posted 5 days ago | Updated 2 days ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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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 22 days ago | Updated 7 hours ago

Senior Data Architect - AWS/Google Cloud Platform

cyberThink, Inc.

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Atlanta, Georgia, USA

Contract

W2 Candidates only - Locals The IT Architect is a member of a team delivering new technology capabilities to the Company s owners, customers, and partners within the organization. The IT Architect helps set the vision and parameters that Agile delivery teams' operation within. In addition, the IT Architect helps build and support governance processes that ensure that team deliverables meet the Company s standards for performance, availability, quality, security, and maintainability. Key Accounta
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Posted 16 days ago

Quality Management Systems (QMS) and Cybersecurity Compliance Specialist

Dew Software

•

Massachusetts, USA

Third Party, Contract

Job Description: Seeking a skilled Quality Management Systems (QMS) and Cybersecurity Compliance Specialist to lead the integration and upgrade of our QMS, assist in internal cybersecurity audits, and provide regulatory submission support (FDA, EU) at our Boston site. The ideal candidate will bring a comprehensive understanding of quality management processes, document control, and corrective and preventive actions (CAPA), with experience supporting regulatory compliance initiatives. Key Respon
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Posted 60+ days ago | Updated 23 hours ago

Systems Engineer

Mindlance

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Remote

Contract

Job Description: Must-Haves: 1. Configuration Management Expertise: Proven understanding and application of configuration management principles and best practices within a complex product development environment. 2. Medical Device Experience: Experience working within the medical device industry or other regulated sectors with knowledge of FDA regulations and ISO standards. 3. Jama Connect Proficiency: Hands-on experience using Jama Connect tool to manage requirements management and traceability
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Posted 60+ days ago | Updated 16 hours ago

Proposal Writer / Proposal Development Specialist

ExpediteInfoTech, Inc.

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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
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Posted 60+ days ago | Updated 7 hours ago