FDA Jobs in Miami, FL

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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

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)

Qualification Engineer II

Katalyst Healthcares and Lifesciences

Davie, Florida, USA

Full-time

Responsibilities: Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP's), Standard Operating Procedures (SOP's). Responsible for completing all training requirements and maintaining 100% compliance with all assignments. dapting Operational Excellence (OpEx) initiatives to improve throughput, reduce waste, improve safety of the existing equipment, utilities and fac

Sr Clinical Engineer Equipment Specialist

Nicklaus Children's Hospital

Miami, Florida, USA

Full-time

Description Job Summary Responsible for providing medical equipment technical support to staff, patients, and administrators relating to Nicklaus Children's Health System's wide life cycle management of medical equipment and systems. Performs routine and complex tasks involved in the installation, maintenance, modification, troubleshooting and calibration of therapeutic, diagnostic, and life support biomedical equipment. Analyzes and corrects problems associated with instrument operation and mal

Senior Full Stack Engineer

Kforce Technology Staffing

Remote or Miramar, Florida, USA

Contract, Third Party

RESPONSIBILITIES: Kforce has a client that is seeking a Senior Full Stack Engineer remotely. Overview: As a Senior Full Stack Engineer, you will design, develop, and maintain web applications across both front-end and back-end systems. You'll work with technologies like Java, Angular, Spring Boot and Spring Reactive and databases to build scalable solutions. In this role, you'll collaborate with teams, teach and mentor junior engineers, and ensure high-quality code and best practices are follow

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

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

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

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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

Senior Level Expert Scientist or Physicist

Spar Information Systems

US

Full-time, Part-time, Third Party, Contract

Hello; Senior Level Expert Scientist or Physicist Job Location:-Remote Long Term 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: 1. Domain-Specific Expertise Must have direct experience building and shipping magnetic tracking solutions-ideally used in catheter navigation, cardiac, gastrointestinal, or surgical

DeltaV Automation Engineer - Pharmaceuticals

Zachary Piper Solutions, LLC

Remote

Full-time

Piper Companies is hiring a DeltaV Automation Engineer for a growing BioPharma company located in Holly Springs, NC. The DeltaV Automation Engineer will be responsible for designing, developing, and maintaining automation systems for pharmaceutical manufacturing processes. This role requires expertise in Emerson DeltaV DCS (Distributed Control System), with a focus on process optimization, validation, and compliance with industry regulations. The DeltaV Automation Engineer can work remote, but w

SAP ABAP Developer

Beacon Systems, Inc

Remote

Third Party, 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: Sap ABAP Developer Location: Jackson, MS (100% Remote) Duration: 5 Years Job Descrip

SAP Lead ABAP Developer

Beacon Systems, Inc

Remote

Third Party, 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: SAP Lead ABAP Developer Location: Jackson, MS (100% Remote) Duration: 5 Years Job De

Principal Product Security Engineer (REMOTE)

Stryker

Remote or Portage, Michigan, USA

Full-time

Work Flexibility: Remote Product Security is driven to make healthcare better by ensuring that Stryker designs, develops, and maintains industry leading cyber secure products for our customers. We are seeking a highly skilled Secure Product Lifecycle Expert to ensure the security of our medical devices across their entire lifecycle. This role is critical in embedding robust security practices into our software development lifecycle (SDL), overseeing post-market security management, and integrat

SAP Financial Consultant

Beacon Systems, Inc

Remote

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 an SAP Financial Consultant - Remote Request you to make sure your updated Resume highlights all the

PeopleSoft Change Management / Training Consultant

Beacon Systems, Inc

Remote

Contract

Hello, I hope this mail finds you well. About Radiant Digital, Inc Radiant Digital, 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 supports 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 worldwid