fda Jobs in san diego, 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

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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 6 days ago | Updated 1 day ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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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 59 days ago | Updated moments ago

Medical Devices Software Program Manager (REMOTE/WEST COAST CANDIDATES)

Amerit Consulting

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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 9 days ago | Updated 3 hours ago

Business Quality Assurance (BQA)

Activesoft, Inc.

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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 25 days ago | Updated 5 hours ago

PTC Arena Consultant

Teknikoz

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Remote

Third Party, Contract

Key Responsibilities:Lead the technical delivery of PLM solutions using PTC Windchill and Arena PLM/QMS. Guide a team of engineers and consultants across India and the USA. Configure, customize, and maintain PLM modules such as BOM, Change Management, Document Control, and Lifecycle Management. Collaborate with business stakeholders to gather requirements and design scalable PLM workflows. Oversee PLM/ERP integrations and ensure data integrity across systems. Provide mentorship, code reviews, an
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Posted 1 day ago | Updated 1 day ago

SAS Programmer

Katalyst Healthcares and Lifesciences

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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.
Posted 13 days ago | Updated 9 hours ago

Director, Biocompatibility Engineering R&D

ICU Medical, Inc.

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San Diego, California, USA

Full-time

Job Description Position Summary The Director of Biocompatibility Engineering will lead the centralized development, implementation, and oversight of biocompatibility programs for ICU Medical's global medical devices. The role will be responsible for overseeing the biocompatibility assessment and testing for all new and existing products. This individual will ensure that all products meet regulatory standards and guidelines related to biological safety and compatibility, particularly the EU Med
Posted 1 day ago | Updated 10 hours ago

Senior Manager Data Management

Katalyst Healthcares and Lifesciences

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San Diego, California, USA

Full-time

Responsibilities: Responsible for data management documentation, including, but not limited to data management plan(DMP), CRF, eCRF design, edit check specifications, data issue logs, and data review plans and ensures all documents follow study design and regulatory requirements. Maintain Data Management outsourcing metrics and key performance indicators to aid the selection of CRO partners / Vendors and the ongoing management of partnerships. Participate in vendor qualifications and audits.
Posted 22 days ago | Updated 9 hours ago

Embedded Linux Engineer

Philips North America

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San Diego, California, USA

Full-time

Job Title Embedded Linux Engineer Job Description We are looking for an Embedded Linux Engineer who will be responsible for the embedded development of portable medical monitoring devices and associated equipment. Your role: Design and develop software and firmware for mobile cardiac monitoring devices, embedded systems, and IoT platforms using C, C++, and Python.Define software architecture and specifications; create detailed design documents aligned with product requirements.Develop embedd
Posted 25 days ago | Updated 10 hours ago

Associate Director, Software Engineering, MMS R&D (Remote)

Becton Dickinson & Company

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Remote or San Diego, California, USA

Full-time

Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human e
Posted 43 days ago | Updated 10 hours ago

Director, Reagent MFG Technical Engineering

Becton Dickinson & Company

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San Diego, California, USA

Full-time

Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human
Posted 60+ days ago | Updated 10 hours ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

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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: Active
Posted 20 hours ago | Updated 8 hours ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

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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 3 days ago | Updated 8 hours ago

Drug Safety Scientist

Sunrise Systems, Inc.

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Remote

Contract

Job Title Drug Safety Scientist Job ID: 25-08470 Location: 100% Remote (Candidates should be in EST only) Duration: 12 months on W2 Contract Summary: Seeking an experienced Drug Safety Scientist with 5+ years in pharmacovigilance to support regulatory safety reporting and risk management. Must hold a Bachelor's/Master s in Pharmacy, Biotechnology, or Chemistry. Key Responsibilities: Author safety reports (DSUR, PBRER, PADER)Support signal detection and safety data evaluationConduct literature
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Posted 3 days ago | Updated 6 hours ago

Remote Senior QA Test Manger/QA Leader with Strong Healthcare Domain

Infinite Computer Solutions (ICS)

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Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Descriptions : We are looking for an experienced Senior QA Healthcare Manager/QA Leader 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: Lead and manage the QA t
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Posted 3 days ago

Senior Expert Physicist

Spar Information Systems

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US

Third Party, Contract

Looking for a Senior-Level Expert-preferably a scientist or physicist-with hands-on experience designing, developing, and troubleshooting magnetic tracking systems, especially in medical device or similar precision environments. Key Requirements: Domain-Specific Expertise Must have direct experience building and shipping magnetic tracking solutions-ideally used in catheter navigation, cardiac, gastrointestinal, or surgical tracking systems. Should be deeply familiar with electromagnetic field be
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Posted 7 days ago | Updated 19 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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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
Posted 22 days ago | Updated 9 hours ago

Oracle Field Service Cloud Consultant

Prutech Solutions

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Remote

Contract

Job Title: Oracle Field Service Cloud Consultant Duration: Full Time / Contract Location : Remote Required Skills/Experience: Bachelors degree in computer science, Information Technology, Engineering, or a related field.5+ years of experience in implementing and supporting Oracle's Field Service solutions.Strong understanding of and field service processes and best practices.Proven expertise in Oracle's E-Business Suite, Cloud, or other relevant Oracle products.Excellent analytical and problem-
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Posted 49 days ago | Updated 4 hours ago

DeltaV Automation Engineer - Pharmaceuticals

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is hiring a DeltaV Automation Engineer for a growing BioPharma company located in Holly Springs, NC. The DeltaV Automation Engineer will be responsible for designing, developing, and maintaining automation systems for pharmaceutical manufacturing processes. This role requires expertise in Emerson DeltaV DCS (Distributed Control System), with a focus on process optimization, validation, and compliance with industry regulations. The DeltaV Automation Engineer can work remote, but w
Posted 6 days ago | Updated 8 hours ago

Principal Product Security Engineer (REMOTE)

Stryker

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Remote or Portage, Michigan, USA

Full-time

Work Flexibility: Remote Product Security is driven to make healthcare better by ensuring that Stryker designs, develops, and maintains industry leading cyber secure products for our customers. We are seeking a highly skilled Secure Product Lifecycle Expert to ensure the security of our medical devices across their entire lifecycle. This role is critical in embedding robust security practices into our software development lifecycle (SDL), overseeing post-market security management, and integrat
Posted 5 days ago | Updated 10 hours ago