FDA Jobs in California

41 - 60 of 128 Jobs

CQV EngineerJob Title - CQV Engineer

Katalyst Healthcares and LifesciencesCompany Name - 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 appJob Title - NPD Test Lead- Embedded systems, Mobile app

Sureminds SolutionsCompany Name - 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

Remote QA Manager with Healthcare Payer and Claims expJob Title - Remote QA Manager with Healthcare Payer and Claims exp

Infinite Computer Solutions (ICS)Company Name - 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 -ContractJob Title - Senior Clinical SAS programmer with Pharma experience -Remonte-W2 -Contract

BiogensysCompany Name - 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 SupervisorJob Title - Packaging Supervisor

Mice GroupsCompany Name - 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 StatisticsJob Title - Sr. Principal Statistics

PARAKEET WORLD SOLUTIONS LLCCompany Name - 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)Job Title - Quality Management Systems (QMS) Specialist (W2)

Sovereign TechnologiesCompany Name - 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 managerJob Title - Clinical Data manager

Intone Networks Inc.Company Name - 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

Sales headJob Title - Sales head

Showman StaffingCompany Name - Showman Staffing

•

Remote

Full-time

Job Title: Sales Head Experience: 6+yrs Location: Remote-Travel required-100% client location 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 w

Sales HeadJob Title - Sales Head

Showman StaffingCompany Name - Showman Staffing

•

Los Angeles, California, USA

Full-time

DTS Lead - Intelligent Clinical Supply ManagementJob Title - DTS Lead - Intelligent Clinical Supply Management

Quantum Integrators Group LLCCompany Name - Quantum Integrators Group LLC

•

Remote or King of Prussia, Pennsylvania, USA

Contract, Third Party

Role Name: DTS Lead - Intelligent Clinical Supply Management (ICSM) Location: King of Prussia, PA. REMOTE 6+ Months contract Job Description The DTS Lead ICSM is responsible for leading the design, implementation, and optimization of SAP's Intelligent Clinical Supply Management (ICSM) solution. This role supports clinical trial operations by ensuring efficient planning, forecasting, packaging, labeling, and distribution of clinical trial materials across global sites, while maintaining regulato

CSV/ CSA EngineerJob Title - CSV/ CSA Engineer

Katalyst Healthcares and LifesciencesCompany Name - 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 SystemsJob Title - Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and LifesciencesCompany Name - 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

Senior Commissioning, Qualification & Validation (CQV) EngineerJob Title - Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

•

Remote or Athens, Georgia, 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

Engineer II, QualityJob Title - Engineer II, Quality

Masimo CorporationCompany Name - Masimo Corporation

•

Irvine, California, USA

Full-time

Job Description Job Summary The Quality Engineer position at Masimo is a multifaceted role that requires a wide breadth of engineering knowledge. An individual in this role will work as part of the Product Assurance department to help drive quality in the company's growing product portfolio. As an integral part of the product development team, quality engineers help guide and direct the team to produce quality products. As a result, a person in this position should be comfortable in all facets

SAS ProgrammerJob Title - SAS Programmer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

San Diego, California, USA

Full-time

Responsibilities: Serves as lead programmer for assigned projects to provide statistical and programming support in one or more Phase I- clinical studies. Design and perform quality checks on analysis datasets, tables, listings, figures (TFL), and written reports to support clinical trial results using SAS. Create and review annotated CRF to STDM datasets. Produce and maintain technical programming specification documents. Lead and actively participate in client and project review meetings.

Engineer II, Quality ComplianceJob Title - Engineer II, Quality Compliance

Masimo CorporationCompany Name - Masimo Corporation

•

Irvine, California, USA

Full-time

Job Description Job Summary The Senior Engineer, Quality Compliance will be responsible for the specific area of Analysis of Data in the Quality Compliance department. This position will interface with representatives from different departments within the organization (e.g. Quality Compliance, Quality Assurance, Engineering, and Operations) to prepare metrics for routine quality reviews and management reviews. This individual will also be responsible for assisting in the development of new pro

Lead Engineer - MES OpcenterJob Title - Lead Engineer - MES Opcenter

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new

Engineer III, ValidationJob Title - Engineer III, Validation

Thermo Fisher ScientificCompany Name - Thermo Fisher Scientific

•

Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn

Engineering Project ManagerJob Title - Engineering Project Manager

Masimo CorporationCompany Name - Masimo Corporation

•

Irvine, California, USA

Full-time

Job Description Job Summary: We are seeking an experienced Engineering Project Manager to lead cross-functional team through product development life cycle for Class II medical device Engineering projects. Responsibilities include developing and maintaining detailed project schedules, facilitating design control activities, managing risk assessments, and coordinating with R&D, Quality, Regulatory, Clinical, Marketing, and Manufacturing teams. The ideal candidate will have a strong background