FDA Jobs in California

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Development Quality Engineer (W2 Only)

Generis TEK Inc.

Pleasanton, California, USA

Contract

We have Contract role Development Quality Engineer (W2 Only) for our client at Pleasanton CA. Please let me know if you or any of your friends would be interested in this position. Position Details: Development Quality Engineer (W2 Only) - Pleasanton CA Location : Pleasanton CA 94588 Project Duration : This is a 12 months contract with potential to extend highly likely Pay Rate : $35.00/hr. on W2 Hours : 8:00am 5.00 PM Job Description We are seeking a motivated and detail-oriented professional t

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's

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

Senior Regulatory Affairs Specialist

ZennSoft

Union City, California, USA

Full-time

Job Title: Senior Regulatory Affairs (RA) Specialist Location: Union City, CA Industry: Medical Devices / Regulatory Affairs Employment Type: Full-Time Client: Lhasa OMS, Inc. About the Role Lhasa OMS, Inc. is seeking a highly motivated Senior Regulatory Affairs Specialist to join our team in Union City, CA. The ideal candidate will support the Regulatory Affairs department by preparing and submitting regulatory documentation for medical devices in both domestic and international markets. This p

Oracle Argus Engineer

Spotline

Alameda, California, USA

Contract

Senior Oracle Argus Engineer Alameda CA Onsite role Job Description: Manage implementation/upgrade/support of Oracle Argus Safety System or other Safety solutions and associated interfaces/integrationsPart of technical workstreams (Configuration/Data Migration/Reporting/Upgrade) and provide progress reports, proposals, requirements documentation, and presentations.As Oracle Argus SME, support technical issues associated with Oracle Argus Safety suite and related interfacesHelp deliver project an

CQV Engineer

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Job Description: We are seeking a highly motivated and experienced CQV Engineer to join PharmEng Technology, a leading global provider of engineering and consulting services to the pharmaceutical and biotechnology industries. The CQV Engineer will lead commissioning, qualification, and validation activities for new and existing pharmaceutical facilities and equipment. Responsibilities: Develop and execute commissioning, qualification, and validation protocols for new and existing pharmaceutical

NPD Test Lead- Embedded systems, Mobile app

Sureminds Solutions

Pleasanton, California, USA

Third Party, Contract

C2C Role Please share Profiles at Hi, Urgent need, Position- NPD Test Lead- Embedded systems, Mobile app (5 days per week onsite ) Location: Pleasanton, CA (Need only Local.) Note- Must to have Medical Domain background NPD Test Lead- Embedded systems, Mobile app to drive the Test strategy , test automation and introduction of cutting-edge medical devices. This role demands deep technical expertise in embedded software, Mobile test automation, regulatory compliance, and cross-functional leade

Caboodle ETL Developer I, II, III, Epic

PIH Health

Whittier, California, USA

Full-time

Determination for the Epic Business Intelligence Developer (I, II or ) roles will be based on experience and qualifications. PIH Health internal applicants or Altera employees (working at PIH Health as of May 2025), Epic certification in the required application/module must be obtained within 120 days of hire or transfer into the position. Failure to obtain certification within this timeframe may result in removal from the position; however, the employee will be eligible to apply for other inte

Caboodle ETL Developer I, II, III, Epic

PIH Health

Whittier, California, USA

Full-time

Determination for the E pic Business Intelligence Developer (I, II or ) roles will be based on experience and qualifications. PIH Health internal applicants or Altera employees (working at PIH Health as of May 2025), Epic certification in the required application/module must be obtained within 120 days of hire or transfer into the position. Failure to obtain certification within this timeframe may result in removal from the position; however, the employee will be eligible to apply for other inte

Remote QA Manager with Healthcare Payer and Claims exp

Infinite Computer Solutions (ICS)

Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Summary: We are looking for an experienced QA Healthcare Manager 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: we need someone who understand healthacre paye

Senior Clinical SAS programmer with Pharma experience -Remonte-W2 -Contract

Biogensys

Remote

Contract

Biogensys is currently hiring a Senior SAS programmer with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Statistical Programmer II: Pharma experience/Remote At least 7-8 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in

Packaging Supervisor

Mice Groups

Livermore, California, USA

Full-time

Job Title: Packaging Supervisor Salary Range: $68,000 $80,000 Shift Preference: Swing shift preferred, but day shift is also an option Job Summary: The Packaging Supervisor oversees employees in a manufacturing and assembly setting. Responsibilities include planning work, enforcing safety and food standards, and improving production processes. Key Duties: Implement and manage production schedulesAssign and supervise line personnelCommunicate with staff about performance, scheduling, and qualityM

Sr. Principal Statistics

PARAKEET WORLD SOLUTIONS LLC

Remote

Contract

Job Title: Sr. Principal StatisticsLocation: Remote Duration: 6 MonthsEmployment Type: W2 ContractExperience Level: Mid-SeniorEducation Required: Ph.D. or MS in Statistics or BiostatisticsIndustry: Pharmaceuticals Job Summary:The Sr. Principal Statistician will lead statistical activities in clinical trials, from protocol development to final study reporting. The role will also contribute to regulatory filings, in-licensing evaluations, and marketing support. Key Responsibilities:Review protocol

Quality Management Systems (QMS) Specialist (W2)

Sovereign Technologies

Irvine, California, USA

Contract

Title: Document Control Coordinator - QMS Location: Irvine, CA Onsite Document Control Specialist QMS Job Description We are seeking a dedicated Quality Management Systems (QMS) Specialist who will play a crucial role in ensuring compliance with internal and external regulatory requirements. This role involves engaging in the development of future state QMS for business needs, executing modifications, and contributing to the quality planning process. Responsibilities Ensure QMS compliance with a

Clinical Data manager

Intone Networks Inc.

Remote

Contract, Third Party

Need stronger with working on Data Acquisition, DTAs and vendor relations. Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.Assist in creating external data transfer agreements, ensuring alignment with Takeda Standards and specifications to support data integration, analysis, and reporting.Provide support in setting up infrastructure for external data to flow into T

JD EDWARD DEVELOPER

Virisha LLC

Remote

Contract

JD Edwards E1 Developer 100% REMOTE but open to working core CST hours 6 month contract to hire Job Description: PREFERRED QUALIFICATIONS: Experience with JDE 9.2+ and Tools Release 9.2.x.Familiarity with BI Publisher, JDE Security, and Workflow.Experience integrating JDE with third-party systems using REST/SOAP APIs.Background in Agile/Scrum or DevOps environments.DUTIES AND RESPONSIBILITIES: Lead the design, development, and implementation of complex customizations and enhancements in JD Edw

Embedded Tester (SIT)

My IT LLC

Alameda, California, USA

Full-time, Contract

Job Title: Embedded Tester (SIT) Location: Alameda, CA (Local candidates only) Contract:6+months Exp. Level: 8-12 years Job Summary: We are seeking a highly skilled and detail-oriented Software Integration Tester (SIT) to join our team in Alameda, CA. This role is focused exclusively on device-level testing for a highly safety-critical handheld medical device. The ideal candidate will have a strong background in embedded systems, particularly in C and C++, and experience working in both RTOS and

Senior Software Quality Engineer, Post Market

Stryker

San Jose, California, USA

Full-time

Work Flexibility: Hybrid Stryker is hiring a Senior Software Quality Engineer, Post Market to support our Medical's Digital Health division and portfolio Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) and Software as a non-medical device (SaND) to support projects as a quality engineer for post-market activities to drive customer quality. Workplace Flexibility & Location: This hybrid role requires candidates to be within commuting distance of one of the following locat

Job Title: Product Manager Healthcare Remote

Think Big Solutions, Inc

Remote

Contract

Job Title: Product Manager Healthcare Location: [City, State or Remote] Job Type: [Full-Time / Part-Time / Contract] Job Summary: We are seeking an experienced and strategic Product Manager with a background in healthcare to lead the development and execution of products that improve patient outcomes, provider workflows, or payer efficiency. The ideal candidate will have a strong understanding of healthcare systems, regulations (e.g., HIPAA, HL7, FHIR), and the complexities of healthcare deliver

Sales head

Showman Staffing

Remote

Full-time

Job Title: Sales Head Experience: 6+yrs Location: Remote-Travel required(100% travel) Job: Permanent Full Time Requirement Role Overview We are seeking a passionate and driven Sales professional to accelerate our growth in the Healthcare and MedTech space one of the most rapidly evolving sectors today. You will work with a high performing team targeting innovative healthcare providers, MedTech firms, and digital health disruptors to bring cutting-edge technology solutions to life. You will repr