FDA Jobs in San Jose, CA

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Regulatory affairs - CMC Manager

Sureminds Solutions

•

Remote

Full-time

PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries. 2. Prep
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Posted 3 days ago

SAP Plant Maintenance (SAP PM)

IT Resonance Inc.

•

Remote

Contract, Third Party

SAP Plant Maintenance (SAP PM) 12 months Remote with travel to onsite (Chicago IL) Must have food & beverage manufacturing or consumer packaged goods industry experience Solid/Strong comm skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards Stephen DJA stephen at itresonance dot com
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Posted 17 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
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Posted 26 days ago | Updated moments ago

Systems Engineer

Mindlance

•

Remote

Contract

Job Description: Must-Haves: 1. Configuration Management Expertise: Proven understanding and application of configuration management principles and best practices within a complex product development environment. 2. Medical Device Experience: Experience working within the medical device industry or other regulated sectors with knowledge of FDA regulations and ISO standards. 3. Jama Connect Proficiency: Hands-on experience using Jama Connect tool to manage requirements management and traceability
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Posted 60+ days ago | Updated 2 days ago

Consultant, XRPD for Solid Oral dosage, GI

Eliassen Group

•

Anywhere, US

Contract

Description: *Remote role* Our F500 Pharma Client is seeking a consultant with strong technical XRPD expertise in solid oral dosage tablet for NDA readiness. We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Rate: $190 - $200 / hr. w2 Experience Requirements: Pharmaceutical Drug Development Experience Solid Oral Dosage Experience Str
Posted 51 days ago | Updated moments ago

Material Handler

Cynet Systems

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Pleasanton, California, USA

Contract

Job Description: Pay Range: $18.50hr - $21.50hr List the significant/essential duties, tasks or responsibilities which employees in this position are required to perform. Perform Material Movements both physically and systematically GeneXX Work Orders from an ERP system Perform Work Order Receipts in ERP system Perform cycle counting as required Maintain a neat and safe work environment Assist in the coordination and flow of product through manufacturing and assembly when needed Work in a cross
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Posted 2 days ago | Updated 17 hours ago

Android Application Developer

OSI Engineering, Inc.

•

San Jose, California, USA

Full-time

Summary: We are seeking a Software Engineer to support the development of a real-time ultrasound imaging platform. The ideal candidate will have a strong foundation in software development principles, and an interest in real-time image processing and medical device software. This role offers the opportunity to work in a fast-paced and research-driven environment, collaborating with an innovative team of engineers to enhance ultrasound imaging technology for healthcare applications. Responsibilit
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Posted 44 days ago | Updated 2 days ago

Process Engineer

1 Point System

•

Hayward, California, USA

Full-time

Job Responsibilities Include Create technical procedures on how to program, install and navigate equipment used by controls engineers and customers. Compile the master Motor and Device List, creating a universal system for electrical devices across multiple types of equipment. Design controls for process equipment following the Food and Drug Administration (FDA) regulations, OSHA regulations, operating procedures, policies, engineering processes, and safety guidelines. Implement the company safe
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Posted 4 days ago | Updated 2 days ago

Senior Android Applications Developer

OSI Engineering, Inc.

•

San Jose, California, USA

Full-time

Summary: We are seeking a highly skilled Senior Software Engineer to develop cutting-edge software for a real-time ultrasound imaging platform. The ideal candidate will have strong expertise in Java/Kotlin (Android), C++, and CUDA, experience with real-time image processing, and a solid understanding of high-performance computing and medical imaging systems. This role requires an adaptable problem-solver who thrives in a fast-moving, research-driven environment and is passionate about advancing
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Posted 44 days ago | Updated 2 days ago

Quality Engineer II - Risk Management

Abbott Laboratories

•

Pleasanton, California, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full li
Posted 25 days ago | Updated 7 hours ago

Development Quality Engineer

Select Source International

•

Pleasanton, California, USA

Contract

Overview: (Master's degrees are overqualified), need bachelor's degree in Computer Science, Biomedical Engineer, Electronics Engineering degree. 100 % Onsite. Will support of Business. Candidates with exposure in software Verification, validations, and testing (Entry level considered). Will be working on tickets, troubleshoot and investigate on the tickets. Working cross functional teams. Test plans and verify changes request. Experience with SQL and Databases is huge plus Software is nice to h
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Posted 46 days ago | Updated 1 day ago

Engineer II, Supplier Quality Assurance

Abbott Laboratories

•

Pleasanton, California, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also hav
Posted 28 days ago | Updated 7 hours ago

Senior Staff AI Data/Validation Engineer

Stryker

•

Menlo Park, California, USA

Full-time

Work Flexibility: Remote What You Will Do: We are looking for an experienced and highly skilled Senior Staff AI Data and Validation Engineer. A successful candidate will be responsible for developing methods and processes for scientific evaluation of AI/ML models used in medical devices, ensuring compliance with all applicable FDA guidelines and regulations. This role is crucial for maintaining the safety, effectiveness, and quality of AI-enabled medical devices throughout their product lifecy
Posted 17 days ago | Updated moments ago

Electrical Engineer I

Abbott Laboratories

•

Pleasanton, California, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Yo
Posted 51 days ago | Updated 22 hours ago

Quality Engineer

Abbott Laboratories

•

Santa Clara, California, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Yo
Posted 18 days ago | Updated 7 hours ago

Senior Program Manager, R&D

Abbott Laboratories

•

Santa Clara, California, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full li
Posted 24 days ago | Updated 22 hours ago

Senior Engineer, Advanced Service Operations

Stryker

•

San Jose, California, USA

Full-time

Work Flexibility: Hybrid Who we want: Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insig
Posted 36 days ago | Updated moments ago

Engineer II, Manufacturing

Abbott Laboratories

•

Pleasanton, California, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full li
Posted 3 days ago | Updated 7 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

•

Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted moments ago

Staff Embedded Software Engineer

Abbott Laboratories

•

Sunnyvale, California, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Yo
Posted 15 days ago | Updated 22 hours ago