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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

IT&D Product Manager Manufacturing

Apex 2000

•

Evansville, Indiana, USA

Contract

IT&D Product Manager Manufacturing Location: Evansville, IN Duration: 9-12 Month Implementing Client: Infosys JD: Position Summary The Manufacturing OT/IT Manager will play a strategic leadership role in the development, integration, and support of Operational Technology (OT) and Information Technology (IT) systems across our manufacturing facilities. This role is critical in ensuring system interoperability, regulatory compliance (GMP, FDA), and the implementation of advanced technologies tha
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Posted 16 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 60+ days ago | Updated moments ago

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

Amerit Consulting

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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

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

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 20 hours ago | Updated 8 hours ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

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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 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 4 days ago | Updated 1 day ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Warsaw, Indiana, USA

Full-time

Responsibilities: Develops and Executes Cleaning Validation Strategies: Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective cleaning processes for medical devices and equipment. Ensures Regulatory Compliance: Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. Analyzes Data and Reports Findings: Compiles and analyzes validation data, writes comprehensive reports, and identifies trends
Posted 23 days ago | Updated 10 hours ago

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

Infinite Computer Solutions (ICS)

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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

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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 1 hour 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 23 days ago | Updated 10 hours ago

Oracle Field Service Cloud Consultant

Prutech Solutions

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Remote

Contract

Job Title: Oracle Field Service Cloud Consultant Duration: Full Time / Contract Location : Remote Required Skills/Experience: Bachelors degree in computer science, Information Technology, Engineering, or a related field.5+ years of experience in implementing and supporting Oracle's Field Service solutions.Strong understanding of and field service processes and best practices.Proven expertise in Oracle's E-Business Suite, Cloud, or other relevant Oracle products.Excellent analytical and problem-
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Posted 50 days ago | Updated 20 hours ago

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
Posted 7 days ago | Updated 8 hours ago

Chemical Process Engineer - Food Manufacturing

Jobot

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Indianapolis, Indiana, USA

Full-time

This Jobot Job is hosted by: Kurt Holzmuller Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $80,000 - $110,000 per year A bit about us: We are a global leader in the consumer packaged goods space. We specialize in enhancing the taste of beverages like coffee, tea, and water through a range of low-calorie sweeteners, creamers, and flavor enhancers. As a process engineer on our team, you will be responsible for leading technical initiatives t
Posted 7 hours ago | Updated 2 hours ago

Principal Product Security Engineer (REMOTE)

Stryker

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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
Posted 6 days ago | Updated 10 hours ago

SAP Financial Consultant

Beacon Systems, Inc

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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
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Posted 4 days ago | Updated 2 days ago

PeopleSoft Change Management / Training Consultant

Beacon Systems, Inc

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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
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Posted 4 days ago

Human Factors Lead

Apidel Technologies

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Remote

Contract

Human Factors Lead (Fully remote job) Job Description: Reporting to the Medical affairs (MA), this role defines work roles and oversees human factors, user experience, and preclinical activities for direct reports and extended core-team team members. Ensures MA function has necessary skills and resources to execute on develop projects as part of business goals and associates are compliant in following procedures. The Senior Manager will lead a Human Factor reviews and all related activity inclu
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Posted 16 days ago | Updated 15 days ago