FDA jobs in Massachusetts

Remote

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13d ago

Position Overview The Clinical QC Consultant is responsible for ensuring the quality, accuracy, and compliance of clinical trial documentation and data. This role supports clinical operations by performing quality control reviews and ensuring adherence to regulatory requirements and internal standards. Key Responsibilities Perform QC review of clinical documents, including:Clinical study reports (CSRs)Protocols and protocol amendmentsInformed consent forms (ICFs)Monitoring visit reportsTrial mas

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Contract

Depends on Experience

IT Validation Lead CSV

North Reading, Massachusetts

•

Today

Job Summary: Looking for an experienced IT Validation Lead with strong CSV/CSA and GxP compliance background to support audit readiness and lead validation activities for IT systems in a life sciences environment. Key Responsibilities: Lead Computer System Validation (CSV) activities across IT systemsSupport audit readiness and act as point of contact for auditsPrepare and review validation documents (IQ/OQ/PQ, risk assessments)Ensure compliance with GxP, GAMP 5, FDA regulationsManage validation

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Contract, Third Party

Depends on Experience

Senior Robotics & Control Software Engineer

Remote or Santa Clara, California

•

Today

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

Full-time

USD 153,000.00 - 187,000.00 per year

Clinical Research Associate (Remote) (West Coast Region)

Remote

•

Yesterday

Please note that this position is a 1 year contract for candidates in the West Coast U.S. Region. Please note that this is a remote position. Submit your rsum only if you live in West Coast region, other candidates will be rejected. Requirements 10 - 12 out of office days per month on average, inclusive to travel.MUST have medical device experience Experience Requirements The ideal candidate will have cardiovascular medical device monitoring experience; however, cardiovascular/electrophysiology

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Contract

Depends on Experience

Clinical Research Associate (Remote) (Northeastern Region)

Remote

•

Yesterday

Please note that this position is a 1 year contract for candidates in the Northeastern U.S. Region. Please note that this a remote position. Candidates only who live in Northeastern US Region submit Resumes all others will be rejected. Requirements 10 - 12 out of office days per month on average, inclusive to travel.MUST have medical device experience Experience Requirements The ideal candidate will have cardiovascular medical device monitoring experience; however, cardiovascular/electrophysiol

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Contract

Depends on Experience

Oracle EBS Process Manufacturing(OPM) functional resource

Remote

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5d ago

Required QualificationsBachelors degree in Engineering, Supply Chain, Business, or related field1418 years of experience as a Oracle EBS Business AnalystStrong understanding of supply chain processes in process industriesPartner with stakeholders across manufacturing, procurement, production, quality, and planning teamsAnalyze and improve end-to-end supply chain processes (demand planning, MRP, inventory, distribution)Identify bottlenecks in batch production, yield variability, and shelf-life co

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Contract, Third Party

80 - 90

CMC Regulatory Technical Writer

Remote

•

Today

Degree in Pharmacy or a relevant science/technical subject such as chemistry, biology, or related field.Minimum of 10 years within a CMC role in the pharmaceutical industry, with at least 5 years being directly involved with a CMC regulatory submission technical writing role.Significant knowledge of CMC-related regulatory requirements and guidelines (e.g., ICH, FDA, EMA) and experience with eCTD submissions.Exceptional technical writing skills with the ability to communicate complex scientific i

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Contract

$50 - $60

Validation Engineer

Raynham, Massachusetts

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Today

Summary: Supports testing and validation activities for medical devices, ensuring compliance with regulatory and quality standards. bility to interpret engineering drawings and specifications. Roles & Responsibilities: Develop Test Protocols aligned with design verification plans and regulatory requirements. Prepare test samples and fixtures for mechanical and functional testing. Execute tests and document results per Good Documentation Practices (GDP). Generate Test Reports for inclusion in the

Full-time

Grafana Architect

Remote or Hybrid in Dallas, Texas

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23d ago

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Job Title: Grafana Architect Location: Hybrid - Dallas, Texas Duration: Long Term Job Descrip

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Contract

Depends on Experience

Sr, Mechanical Engineer (Medical Device)

Marlborough, Massachusetts

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Today

Location: Marlborough, MA Salary: $100,000.00 USD Annually - $140,000.00 USD Annually Description: One of our clients is looking to hire on a Senior Mechanical Engineer role supporting the development of laser-based medical devices. This position is fully onsite in Marlborough, MA and offers the opportunity to lead complex opto-mechanical systems through the full product lifecycle from design input through V&V and manufacturing transfer. Highlights of the role: Senior-level ownership of med

Contract

USD 100,000.00 - 140,000.00 per year

Medical Surgical Fiber Product Engineering Manager

Marlborough, Massachusetts

•

Today

Location: Marlborough, MA Salary: $150,000.00 USD Annually - $180,000.00 USD Annually Description: Position Overview The Engineering Manager will lead all research and development efforts for the company's medical fiber product portfolio, with a strong emphasis on innovation, product reliability, and alignment with strategic business goals. This role oversees the full product design lifecycle-from defining design inputs and outputs, through verification and validation, to successful transfe

Contract

USD 150,000.00 - 180,000.00 per year

Cloud Platform Architect

Remote

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16d ago

Role:Cloud/Platform Architect Location:Remote Type: Full time Role Summary Lead end-to-end architecture and delivery governance for a regulated AWS platform supporting CDAP (pharmacometrics) and BEE (biostats). Own multi-environment architecture (DEV/TEST/PROD/DR) using Terraform modularization and GitOps practices. Define platform blueprint for compute, storage, networking, identity, CI/CD, observability, DR, and operational readiness. Key Responsibilities Define target AWS architecture for VP

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Full-time, Third Party

1,20,000 - 1,30,000

Quality Assurance Inspector - V

Andover, Massachusetts

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Today

Title: Quality Assurance Inspector - V Location: 1 BURTT ROAD, Andover, MA, USA, 01810 Duration: 12+ months (possible for extensions) Job Description: The main function of a Quality Assurance Inspector is to ensure that products, materials, and processes meet established quality standards and regulatory requirements. A typical Quality Assurance Inspector performs inspections, documents findings, and collaborates with production teams to maintain consistent product quality. Job Responsibilitie

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Contract, Third Party

$Market

Robotics Project Engineer

Remote or New Jersey

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Today

Responsibilities: Support the execution of robotics projects at multiple US sites including Puerto Rico, contributing to planning, implementation, and delivery. Collaborate with cross-functional site teams to clearly define project scope, objectives, and deliverables that align with both business and technical needs. Build and maintain strong relationships with site teams, stakeholders, and vendors to anticipate challenges, resolve roadblocks, and ensure successful project outcomes across a rang

Full-time

Robotics Project Engineer

Cambridge, Massachusetts

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Today

Full-time

Cloud/Platform Architect - Cambridge, MA (Hybrid)

Cambridge, Massachusetts

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Yesterday

Role : Cloud/Platform Architect Location : Cambridge, MA (Hybrid) Required Experience: 15 20 years Role Summary Lead end-to-end architecture and delivery governance for a regulated AWS platform supporting CDAP (pharmacometrics) and BEE (biostats). Own multi-environment architecture (DEV/TEST/PROD/DR) using Terraform modularization and GitOps practices. Define platform blueprint for compute, storage, networking, identity, CI/CD, observability, DR, and operational readiness. Key Responsibili

Full-time, Contract, Third Party

Staff Software Engineer- Medical Device Embedded SW (Hybrid)

Remote or Portage, Michigan

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Today

Work Flexibility: Hybrid or Onsite We are seeking a highly experienced Staff Software Engineer to help design, develop, and maintain software for safety-critical medical devices. This role requires deep technical expertise in embedded and application software, strong technical leadership, and hands-on experience developing software in regulated medical device environments. You will play a key role in defining software architecture, guiding technical decisions, and ensuring compliance with appl

Full-time

Blue Yonder Wms Architect/consultant

Remote

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Yesterday

We are seeking an experienced, highly skilled Blue Yonder WMS Solution Consultant/Architect to join our team and play a critical role in the successful delivery of a Blue Yonder Warehouse Management System (WMS) transformation project for our clients in the healthcare distribution sector. This role will lead the architectural design, technical implementation, and deployment of the Blue Yonder WMS solution. The ideal candidate will be a technical expert in Blue Yonder WMS, possess a strong unders

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Contract, Third Party

Depends on Experience

Quality Lead, Software and IT Compliance

Remote or LASARA, Tx

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Today

Description: Remote The organization seeks a Quality Lead to maintain and improve the Quality Management System and ensure compliance with FDA and international regulations across enterprise software initiatives. The role shall author and guide SDLC deliverables, lead validation and risk activities, and provide expert quality guidance to IT and software teams. The position will support complex enterprise systems, drive continuous improvement, and collaborate across functions to meet regulatory

Contract

In House CRA

Remote or Jacksonville, Florida

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Today

In-House Clinical Research Associate I Summary: The In-House CRA I is based in the client's facility and will provide clinical research support and assistance in overseeing the conduct of clinical trials. Responsibilities: Work to ensure that trials are adhere to study protocols, applicable SOPs, FDA regulations, International Conference for Harmonization (ICH) / Good Clinical Practices (Google Cloud Platform) guidelines, and government regulations. Evaluate, monitor, and document study resu

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FDA jobs in Massachusetts, USA