FDA Jobs in California

Refine Results
1 - 20 of 140 Jobs

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
Easy Apply
Posted 7 days ago | Updated 1 day ago

Manager - Medical Affairs

NexInfo Solutions, Inc.

•

Foster City, California, USA

Contract

About Nexinfo: NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges
Easy Apply
Posted 2 days ago | Updated 1 day ago

Electrical Safety Engineer

Innova Solutions, Inc

•

Lake Forest, California, USA

Full-time

An Innova Solutions Client is immediately hiring for a Electrical Safety Engineer Position type: Fulltime Location: Lake Forest, CA-Onsite As an Electrical Safety Engineer, you will need: Minimum Qualifications: Job description: 4+ years of total experience.Electrical Engineering (or similar) with experience in medical device safety compliance .Expert knowledge of IEC 60601-1 for medical electrical equipment.Familiar with FDA Approval process.Proven experience working cross-functionally with R&D
Easy Apply
Posted 31 days ago

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
Easy Apply
Posted 59 days ago | Updated 1 hour ago

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
Easy Apply
Posted 9 days ago | Updated 11 hours ago

Electrical Engineer

Innova Solutions, Inc

•

Lake Forest, California, USA

Contract, Third Party

A client of Innova Solutions is looking for an Electrical Safety Engineer Position type: Contract Duration: 12+ Months Location: Lake Forest, CA (Onsite) As an Electrical Safety Engineer, you will: Minimum Qualifications: Electrical Engineering (or similar) with experience in medical device safety compliance .Expert knowledge of IEC 60601-1 for medical electrical equipment.familiar with FDA Approval processProven experience working cross-functionally with R&D teams and external labs for safety
Easy Apply
Posted 60+ days ago | Updated 17 days 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)
Easy Apply
Posted 25 days ago | Updated 13 hours ago

PTC Arena Consultant

Teknikoz

•

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
Easy Apply
Posted 1 day ago | Updated 1 day ago

Senior Software Engineer

Long Finch Technologies

•

Irvine, California, USA

Contract

Job DescriptionRoles and ResponsibilitiesDesign, implement, debug, and test embedded software for regulated medical devices (Class B/C).Deliver robust, maintainable, and testable code aligned with system requirements and safety standards.Conduct thorough unit testing, static analysis, code reviews, and integration testing to ensure software quality.Collaborate with electrical, mechanical, systems, and software engineering teams to define interfaces and system behaviors.Support hardware/software
Posted 7 hours ago

Embedded Software Test Engineer

DCE Infosec LLC

•

Irvine, California, USA

Contract

Must be local to Irvin, CA 10+ years of experience is must Job Description: Proficient in embedded C/C++ programming; working knowledge of Python for scripting test and automation tasks.Solid understanding of real-time operating systems (RTOS), interrupt handling, memory management, and hardware abstraction.Skilled in device driver development; ability to read and interpret hardware data sheets and schematics is a plus.Strong debugging and troubleshooting skills using tools such as debuggers, os
Easy Apply
Posted 1 day ago

Senior Hardware Test Engineer

Katalyst Healthcares and Lifesciences

•

Santa Rosa, California, USA

Full-time

Responsibilities: Perform hardware functional verification and testing. Develop and update hardware test protocols for medical device hardware components. Perform design specifications review and approval for new and existing medical devices. Identify and validate alternative components to address obsolescence issues in medical device hardware. Collaborate with cross-functional teams to ensure compliance with regulatory standards and quality requirements. Contribute to risk analysis and ma
Posted 23 days ago | Updated 7 hours ago

Computer Systems Validation Engineer

Corporate Solutions General, Inc.

•

San Francisco, California, USA

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

Role: Computer System Validation Engineer (Hybrid- 3 days a week Onsite in San francisco CA) Contract: 6 months with possible extension\ Minimum 10+ Years experience required .5 year in Pharma domain Job Roles and Responsibilities: * Develop, execute, and document test protocols for system qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). * Ensure that software is properly validated and compliant with internal and exter
Easy Apply
Posted 10 hours 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 4 hours 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 1 day ago | Updated 4 hours ago

Embedded Software Engineer

DCE Infosec LLC

•

Irvine, California, USA

Contract

Must be local to Irvin, CA Job Description: Design, implement, debug, and test embedded software for Class B and Class C medical devices using C/C++ and Python.Deliver high-quality, testable, and maintainable code that meets functional, performance, and safety requirements.Ensure embedded software design robustness through unit testing, static analysis, code reviews, and integration testing.Work closely with electrical, mechanical, systems, and software teams to define embedded software interfac
Easy Apply
Posted 1 day ago

Senior Software Engineer

Learn Beyond Consulting LLC

•

Irvine, California, USA

Full-time

Role: Senior Software EngineerLocation: Irvine, CA Job Description:Design, implement, debug, and test embedded software for Class B and Class C medical devices using C/C++ and Python.Deliver high-quality, testable, and maintainable code that meets functional, performance, and safety requirements.Ensure embedded software design robustness through unit testing, static analysis, code reviews, and integration testing.Work closely with electrical, mechanical, systems, and software teams to define emb
Easy Apply
Posted 2 days ago | Updated 12 hours ago

Senior Quality Lead-ISO 17025 Auditor-W2 ONLY

VetForce Solutions

•

Los Angeles, California, USA

Contract

Lead and support the remediation of previous audit observations, including root cause analysis, risk based corrective action planning, and effectiveness verification. Coordinate and conduct 6 onsite internal audits of laboratory operations and management systems to assess compliance with ISO 17025. Identify nonconformities, document audit findings, and develop actionable recommendations. Maintain audit schedules, records, and reporting documentation. Support accreditation readiness and provide g
Easy Apply
Posted 13 hours ago | Updated 13 hours ago

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
Easy Apply
Posted 4 days ago | Updated 14 hours ago

Mechanical Engineer

Jobot

•

Vista, California, USA

Full-time

Excellent Opportunity to Join a Fast Growing Manufacturing Company! Competitive Salary and Stellar Benefits! This Jobot Job is hosted by: Jaclyn D'Amore Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $85,000 - $100,000 per year A bit about us: We are seeking an experienced Manufacturing Engineer with a strong background in project management and regulated manufacturing environments. This individual will drive continuous improvement, optimi
Posted 2 days ago | Updated 3 hours ago

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
Easy Apply
Posted 4 days ago