FDA Jobs in San Francisco, CA

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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 4 days ago | Updated 1 day 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 56 days ago | Updated 4 hours 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
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Posted 6 days ago | Updated 13 hours 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 22 days ago | Updated 13 hours ago

CSV/ CSA Engineer

Katalyst Healthcares and Lifesciences

•

San Francisco, California, USA

Full-time

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Responsibilities: 10 Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnology. Stron
Posted 20 days ago | Updated 10 hours 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 12 days ago

SQA-Python NO C2C/LOCAL ONLY

Johnson Service Group, Inc.

•

Alameda, California, USA

Contract

Johnson Service Group is looking for 2 Senior Level Test Automation Engineers (SDET) to work on-site with our client with locations in Alameda, CA, Milpitas, CA and Portland, OR. In this position, you will test applications and work collaboratively with the development team to ensure the delivery of quality products in an efficient, timely manner. The successful candidate will work within the client s high-performance development team that is developing world-class products in patient healthcar
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Posted 5 days ago

Systems Administrator / Technical Lead - Process Control Systems

Katalyst Healthcares and Lifesciences

•

Foster City, California, USA

Full-time

Job Summary: We are looking for an experienced professional who will be responsible for administration of Rockwell FactoryTalk-based process control systems and Inductive Automation's Ignition-based process control and environmental monitoring systems. The candidate should have hands-on experience deploying, configuring, and troubleshooting these systems in a Good Manufacturing Practice (GMP) environment, with a good understanding of FDA regulations. This role focuses on deploying system updates
Posted 20 days ago | Updated 10 hours ago

Quality System Specialist

Radiant System, Inc

•

Hercules, California, USA

Contract

Description: The Quality System Specialist will assist in the updating and consolidation of legacy product technical and risk management files related to IVDR. Responsibilities include:Facilitating risk management assessments, updating risk plans and reports, and consolidating and updating product system hazard analysis files in accordance with established company procedures and applicable standards.Coordinating and facilitating meetings with cross-functional stakeholders as necessary to gather
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Posted 4 days ago | Updated 11 hours ago

Systems Administrator / Technical Lead Process Control Systems

I.T. Solutions

•

Foster City, California, USA

Contract

Job Title: Systems Administrator / Technical Lead Process Control Systems Location: Foster City, Onsite (5 days a week) Duration: Long Term Contract Job Summary: We are looking for an experienced professional who will be responsible for administration of Rockwell FactoryTalk-based process control systems and Inductive Automation s Ignition-based process control and environmental monitoring systems. The candidate should have hands-on experience deploying, configuring, and troubleshooting these sy
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Posted 27 days ago | Updated 25 days ago

Regulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site)

Abbott Laboratories

•

Alameda, 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 60+ days ago | Updated 5 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 30 days ago | Updated 10 hours ago

Maintenance Manager, Bakery

Aspire Bakeries

•

Newark, California, USA

Full-time

Aspire Bakeries is a North American baking company with a leadership position in specialty frozen baked goods. Formed from leading bakery companies, its innovative food portfolio includes breads, artisan breads, buns, cookies, donuts, muffins and pastries from beloved brands like , , and . With 13 bakeries in North America, we are committed to driving innovation, predicting upcoming consumer trends and flavors, and exceeding our customers' expectations. Aspire Bakeries champions the values of
Posted 20 days ago | Updated 15 hours ago

Sr Account Manager - Bay Area

LSG Sky Chefs

•

San Francisco, California, USA

Full-time

Job Title: Sr Account Manager - Bay Area Job Location: San Francisco-USA-94128 Work Location Type: On-Site Salary Range: $123,266.53 - 159,935.96 About us LSG Sky Chefs is one of the world's largest airline catering and hospitality providers, known for its outstanding reputation and dynamic approach in the industry. Voted "Airline Caterer of the Year in North America" for 2023 and 2024, we are committed to excellence and innovation, driven by the dedication and expertise of our talented employee
Posted 47 days ago | Updated 10 hours ago

Clinical Project Manager

Abbott Laboratories

•

Alameda, 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. Clinical Project Manager Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your tru
Posted 15 days ago | Updated 1 hour ago

Digital Health Product Manager

Tranzeal, Inc.

•

Foster City, California, USA

Contract

Role: Digital Health Product Manager Location: Foster City, CA (Hybrid) We are seeking an experienced Digital Health Product Manager (Patient & Provider Solutions) to lead critical product development efforts across a portfolio of digital patient and provider solutions. This engagement will focus specifically on enhancing patient support through SMS and two-way communication platforms, building innovative virtual training products for nurse educators (including areas like injection administratio
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Posted 25 days ago

Product Manager

Devfi

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Foster City, California, USA

Contract

Product Manager - Digital Health Foster City, California- 3 days a week in-person at the Foster City, CA 6 Months Project Overview: We are seeking an experienced Digital Health Product Manager to lead critical product development efforts across a portfolio of digital patient and provider solutions. This engagement will focus specifically on enhancing patient support through SMS and two-way communication platforms, building innovative virtual training products for nurse educators (including areas
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Posted 25 days ago

QARA Project Manager

Abbott Laboratories

•

Alameda, 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 60+ days ago | Updated 5 hours ago

Systems Engineer 2 of 2

Johnson & Johnson

•

Remote or Santa Clara, California, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 1 day ago | Updated 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 1 day ago | Updated 7 hours ago