FDA Jobs in Massachusetts

21 - 40 of 99 Jobs

CQV EngineerJob Title - CQV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Senior Validation EngineerJob Title - Senior Validation Engineer

Takeda pharmaceuticalCompany Name - Takeda pharmaceutical

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Lexington, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by

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)

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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

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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

Senior C++ QT Software Engineer - Med DeviceJob Title - Senior C++ QT Software Engineer - Med Device

Motion Recruitment Partners, LLCCompany Name - Motion Recruitment Partners, LLC

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Marlborough, Massachusetts, USA

Full-time

Our client, a leading innovator in the medical device industry, is seeking a Senior Software Engineer with strong expertise in C++, Qt, and image processing/computer vision. This role offers the opportunity to contribute to advanced diagnostic and imaging solutions that have a real impact on patient care. Key Responsibilities: Design, develop, and maintain software applications using C++ and the Qt frameworkImplement and optimize algorithms for image processing and computer visionCollaborate wit

Sr. Principal StatisticsJob Title - Sr. Principal Statistics

PARAKEET WORLD SOLUTIONS LLCCompany Name - PARAKEET WORLD SOLUTIONS LLC

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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

Clinical Data managerJob Title - Clinical Data manager

Intone Networks Inc.Company Name - Intone Networks Inc.

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Remote

Contract, Third Party

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

Clinical SAS programmerJob Title - Clinical SAS programmer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures, and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases. Perf

JD EDWARD DEVELOPERJob Title - JD EDWARD DEVELOPER

Virisha LLCCompany Name - Virisha LLC

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Remote

Contract

JD Edwards E1 Developer 100% REMOTE but open to working core CST hours 6 month contract to hire Job Description: PREFERRED QUALIFICATIONS: Experience with JDE 9.2+ and Tools Release 9.2.x.Familiarity with BI Publisher, JDE Security, and Workflow.Experience integrating JDE with third-party systems using REST/SOAP APIs.Background in Agile/Scrum or DevOps environments.DUTIES AND RESPONSIBILITIES: Lead the design, development, and implementation of complex customizations and enhancements in JD Edw

Principal Validation EngineerJob Title - Principal Validation Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

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Danvers, Massachusetts, 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

Job Title: Product Manager Healthcare RemoteJob Title - Job Title: Product Manager Healthcare Remote

Think Big Solutions, IncCompany Name - Think Big Solutions, Inc

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Remote

Contract

Job Title: Product Manager Healthcare Location: [City, State or Remote] Job Type: [Full-Time / Part-Time / Contract] Job Summary: We are seeking an experienced and strategic Product Manager with a background in healthcare to lead the development and execution of products that improve patient outcomes, provider workflows, or payer efficiency. The ideal candidate will have a strong understanding of healthcare systems, regulations (e.g., HIPAA, HL7, FHIR), and the complexities of healthcare deliver

Sales headJob Title - Sales head

Showman StaffingCompany Name - Showman Staffing

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Remote

Full-time

Job Title: Sales Head Experience: 6+yrs Location: Remote-Travel required(100% travel) 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 will repr

Software Verification EngineerJob Title - Software Verification Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Newton, Massachusetts, USA

Full-time

Job Description: We are seeking a meticulous and detail-oriented Medical Device Software Verification Tester to join our team. The successful candidate will be responsible for verifying software used in our medical devices and ensuring compliance with regulatory standards and internal quality requirements. This role involves designing, implementing, and executing test plans and procedures to identify and document software defects. Responsibilities: Test Planning and Design. Develop comprehensi

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

Quantum Integrators Group LLCCompany Name - Quantum Integrators Group LLC

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Remote or King of Prussia, Pennsylvania, USA

Third Party, Contract

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

Software Engineer - Embedded C, C#, C++ | Marlborough, MAJob Title - Software Engineer - Embedded C, C#, C++ | Marlborough, MA

Michael Page InternationalCompany Name - Michael Page International

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Marlborough, Massachusetts, USA

Full-time

Join a revolutionary medical device manufacturing organizationWork with a team making a difference to patients all over the world About Our Client The company is a medical device organization that design and develop cutting-edge software for complex medical devices. They have an FDA approved device that is live in the US, Europe & Asia and they're looking to further grow their R&D team with this hire, and plan to continue their growth for the remainder of 2025 and into 2026! Job Description

Automation EngineerJob Title - Automation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Framingham, Massachusetts, USA

Full-time

Roles & Responsibilities: Lead design, configuration, and commissioning of DeltaV and Client-X automation systems for GMP-critical manufacturing equipment and process controls. Support change controls, deviations, and CAPAs involving DeltaV and Client-X logic, batch strategies, and alarm configuration in collaboration with QA and Validation. Develop and modify control modules, phases, and equipment modules within DeltaV in alignment with S88 batch architecture standards. Provide hands-on trouble

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

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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

Senior Mechanical EngineerJob Title - Senior Mechanical Engineer

Motion Recruitment Partners, LLCCompany Name - Motion Recruitment Partners, LLC

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Boston, Massachusetts, USA

Full-time

Our client, a leading medical device company, is seeking a Senior Mechanical Engineer to join their R&D team. This role involves contributing to the design, development, and support of diagnostic systems and electromechanical components in a regulated environment. The ideal candidate will have a strong background in mechanical design, experience with complex assemblies, and a track record of bringing products from concept through development and into manufacturing. This is a hands-on engineering

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

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

Site Compliance Quality HeadJob Title - Site Compliance Quality Head

Software Guidance & AssistanceCompany Name - Software Guidance & Assistance

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Billerica, Massachusetts, USA

Full-time

Software Guidance & Assistance, Inc., (SGA), is searching for a Site Compliance Quality Head for a FULL-TIME assignment with one of our premier Pharmaceutical Services clients in Billerica, MA. Responsibilities: Implement and manage the records in electronic Quality Systems, such as QMS, EDMS, and LMS, etc. providing procedures and training for employees to effectively use the electronic Quality Systems Supervise the QA Documentation department in the creation, issuance, maintenance, archivi