fda Jobs in california

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Sr. Embedded Software Engineer

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. You'

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

Sr Embedded Software Engineer

Abbott Laboratories

San Diego, 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

Statistical Programmer needed for Remote Job only EST candidates needed!!!

Nam Info Inc

Remote or US

Full-time, Third Party, Contract

Dear, Hope you are doing well. Send resumes along with expected bill rates on W2( NO Benefits) or Independent contractors only apply and share to Note : NO 3rd party candidates, or H1's/EAD's/OPT's please. Role :Statistical Programmer II Location :Remote Duration : 6+ months contract EST ZONE CANDIDATES ONLY Statistical Programming II: Key responsibilities At least 5 years of experience in ADaM/TLF. Create, validate, and maintain SAS programs for data analysis, reporting, and submission de

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

Sr MES PharmaSuite Consultant

Swanktek

Vacaville, California, USA

Contract

Client is seeking a highly experienced and resilient Senior Pharma Suite Owner's Representative to join our client's critical automation system replacement project in their state-of-the-art biopharmaceutical manufacturing facility. This individual will act as a key liaison, advocating for the client's best interests and ensuring the successful implementation of the Rockwell PharmaSuite MES. This is a demanding, long-term contract role requiring a professional who thrives in a high-pressure envir

Clinical Data manager

Intone Networks Inc.

Remote

Third Party, Contract

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

LIMS CONSULTANT

Recruitment.ai

San Francisco, California, USA

Full-time

Job Title: Senior Consultant - Clarity LIMS Location: Bay Area, CA (Onsite) About the RoleWe are seeking a highly experienced Clarity LIMS Developer to lead the design, configuration, customization, and integration of Illumina s Clarity Laboratory Information Management System (LIMS). The ideal candidate will have experience in LIMS development, with significant expertise in Clarity LIMS, preferably in a regulated or high-throughput laboratory environment. Key ResponsibilitiesSystem Design & Con

Business developer Manager

Showman Staffing

Remote

Full-time

Job Title: Sr.Business Developer Manager Experience: 6+yrs Location: Remote-Travel required-100% client location-Candidates should be in USA 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 c

Senior Business Developer Manager

Showman Staffing

Remote

Full-time

Job Title: Sr.Business Developer Manager Experience: 6+yrs Location: Remote-Travel required-100% client location-Candidates should be in USA 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 c

Senior Business Development Manager

Showman Staffing

Remote

Full-time

Job Title: Sr. Business Development Manager Experience: 6+yrs Location: Remote-Travel required-100% client location-Candidates should be in USA 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 brin

R&D Systems Electrical Engineer

Swanktek

Santa Clara, California, USA

Full-time

The Staff R&D Systems Electrical Engineer, Systems will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. This individual will support product testing, sub-system/component qualification and design, and serve on multiple cross-functional initiatives for projects ranging from concept through commercialization. Essential Responsibilities Design, develop, and troubleshoot electro-mechanical products in full compliance with compan

Senior Compliance Software Engineer (Product)

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. Senior Compliance Software Engineer (Product) Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and fam

Sr. Product Security Engineer (San Diego, CA office)

Abbott Laboratories

San Diego, 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

Sr. Staff Embedded Software Engineer

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. You'

compliance lead

Adva IT Services, Inc..

Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc

Systems Engineer III

Abbott Laboratories

Milpitas, 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. The Opportunity: The opportunity is located in Milpitas, California. We are looking for an individual who has the ability to work within and influen

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

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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