FDA Jobs in Seattle, WA

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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 8 days ago | Updated 2 days ago

Clinical Development Scientist

ComTec Information Systems

•

Bothell, Washington, USA

Contract

Clinical Development Scientist Hybrid role. 3 days/week in office Bothell WA/Cambridge MA/ Plymouth MN 12 Months Ultrasound, Senior Clinical Development Scientist The Senior Clinical Development Scientist for the Ultrasound group will be responsible for developing, generating, and disseminating clinical and economic evidence ensuring innovation, and transformation with best-in-class clinical evidence. Your role: Contribute strategic guidance for clinical and economic evidence related to the en
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Posted 5 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.

•

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

Sr. Principal Software Quality Engineer

Katalyst Healthcares and Lifesciences

•

Bellevue, Washington, USA

Full-time

Responsibilities: Partner with development teams to ensure compliance with FDA, ISO 13485, IEC 62304, ISO 14971, and cybersecurity standards. Provide quality oversight for Design History Files (DHF), risk management, V&V, and design controls. Lead software risk management (RMF), including risk evaluation, control, and mitigation. Drive Secure Product Development Framework (SPDF) and software security best practices. Support Agile software development teams, ensuring regulatory and quality compli
Posted 24 days ago | Updated 3 hours ago

Material Handler

TSR Consulting Services, Inc.

•

Bothell, Washington, USA

Contract

Our client, a leading pharmaceutical company, is hiring a Material Handler, on a contract basis. Job ID: 82575 Work Location: Bothell, WA - 100% on site Summary: The primary focus of the role will be to provide material movement and logistical support to internal and external customers in support of cellular therapeutic manufacturing at the Juno Manufacturing Plant (JuMP) during process transfers, routine production, and technology improvements that support manufacturing operations. The key del
Posted 3 days ago | Updated 11 hours ago

Material Handler

LOGIXtech Solutions

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Bothell, Washington, USA

Contract

Our client, a leading pharmaceutical company, is hiring a Material Handler, on a contract basis. Job ID: 82575 Work Location: Bothell, WA - 100% on site Summary: The primary focus of the role will be to provide material movement and logistical support to internal and external customers in support of cellular therapeutic manufacturing at the Juno Manufacturing Plant (JuMP) during process transfers, routine production, and technology improvements that support manufacturing operations. The key del
Posted 3 days ago | Updated 11 hours ago

Urgent Requirement --Embedded Software Engineer-- Bothell, WA (Onsite)-- Having Urgent Interviews

Alpha Silicon

•

Bothell, Washington, USA

Contract, Third Party

The Role: Design and develop software technological solution, platform, or reference Design, Code and Test (unit and integration) for embedded systems Participates in determining the system, subsystem, and interfaces between them Validates technology assumptions, evaluates alternatives, and defines functional and non-functional requirements Test and review codes You're the right fit if: This position requires a minimum of a BS in Software/Electrical/Computer Engineering or equivalent from an acc
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Posted 23 days ago | Updated 1 day ago

Data Support Analyst

Robert Half

•

Redmond, Washington, USA

Contract

Description Are you ready to dive into a dynamic role where your attention to detail and problem-solving skills can make a real impact? We're looking for a Data Support Analyst to join our team on a long-term contract to help us optimize the management and accuracy of product data in our ERP systems. This is your chance to work independently on meaningful projects, collaborate with cross-functional teams, and create value in business processes related to product master data. What You'll Do: As
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Posted 22 days ago | Updated 11 hours ago

Compliance Specialist V (Environmental, Health, and Safety Engineer)

OrangePeople

•

Redmond, Washington, USA

Contract

OrangePeople, we're more than a consulting firm-we're a people-first, high-touch organization committed to delivering transformative technology solutions with integrity and passion. Currently, we are seeking an Environmental, Health, and Safety (EHS) Engineer with an emphasis on Laser Safety in Redmond, WA. The EHS Engineer role will primarily support the radiation and laser safety team through area assessments, evaluating equipment purchase requirements, reviewing R&D experiments, and performi
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Posted 60+ days ago | Updated 1 day 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: Acti
Posted 1 day ago | Updated moments 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: Active
Posted 2 days ago | Updated moments 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 5 days ago | Updated 1 day 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 5 hours 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 24 days ago | Updated 3 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 51 days ago | Updated 1 day 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 8 days ago | Updated moments ago