fda Jobs in massachusetts

1 - 20 of 102 Jobs

Remote - Senior Project Manager with FDA and GxP experience - CHJob Title - Remote - Senior Project Manager with FDA and GxP experience - CH

Empower ProfessionalsCompany Name - Empower Professionals

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Remote

Contract, Third Party

Role: Senior Project Manager location: Remote Duration: 12+ Month Level Skill Core Concepts Expert Product Lifecycle Management (PLM) Systems Windchill, Teamcenter, Change Management, Product Data Management, Configuration Control Expert Medtech Regulatory Compliance Knowledge FDA 510K, PMA, UDI, CE mark, EU MDR, GxP, FURLS, BUDI Expert Stakeholder Management and Influence Cross-functional influence, Stakeholder mapping, SME engagement, Interpersonal diplomacy Proficient Cross-OUs Regulatory Pro

Regulatory affairs - CMC ManagerJob Title - Regulatory affairs - CMC Manager

Sureminds SolutionsCompany Name - Sureminds Solutions

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Remote

Full-time

PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries. 2. Prep

Product Security EngineerJob Title - Product Security Engineer

Vankay SystemsCompany Name - Vankay Systems

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Danvers, Massachusetts, USA

Contract

Role: Product Security Engineer Hiring Mode: Contract (TP) Location: Danvers, MA-01923 [On-site] Skills Matrix Skill Last Used Experience in Years/month Rating (10 points) 1 = newbie 10 = expert Hands on Exp. Yes/No Security risk management techniques Regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR) Pre-market product development activities Medical devices FDA Job Description: 5+ years industry experience in Information Security.Wor

Project Manager (Artwork integration and system upgrade)Job Title - Project Manager (Artwork integration and system upgrade)

InfoObjects IncCompany Name - InfoObjects Inc

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Remote

Contract

Project Manager Artwork integration and system upgrade Location: 100% remote (Ideally EST time zone) Duration: 6+ Months Contract Responsibilities: Lead and manage IT projects supporting 3PL-related business process improvements and integration into US operations.Oversee the upgrade and implementation of software related to labeling and artwork management.Coordinate across international teams and departments to drive project milestones and ensure cross-functional collaboration.Keep senior manufa

SAP Plant Maintenance (SAP PM)Job Title - SAP Plant Maintenance (SAP PM)

IT Resonance Inc.Company Name - IT Resonance Inc.

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Remote

Third Party, Contract

SAP Plant Maintenance (SAP PM) 12 months Remote with travel to onsite (Chicago IL) Must have food & beverage manufacturing or consumer packaged goods industry experience Solid/Strong comm skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards Stephen DJA stephen at itresonance dot com

LIMS and QC Applications ConsultantJob Title - LIMS and QC Applications Consultant

Expedite Technology SolutionsCompany Name - 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

Business Quality Assurance (BQA)Job Title - Business Quality Assurance (BQA)

Activesoft, Inc.Company Name - 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)

Sr.Quality System EngineerJob Title - Sr.Quality System Engineer

Cygtec IncCompany Name - Cygtec Inc

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Danvers, Massachusetts, USA

Contract

Job Title: Sr. Quality Systems Engineer Rate: Open based on Experience Location : Onsite- Danvers, MA (Hybrid) Principle Duties and Responsibilities: Must have in depth knowledge of and ability to apply quality system regulation, including QSR, ISO 13485, MDSAP and MDD/MDR.Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.Contribute to the development of Quality System perfor

Product Security EngineerJob Title - Product Security Engineer

Talent GroupsCompany Name - Talent Groups

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Danvers, Massachusetts, USA

Third Party, Contract

Role: Product Security Engineer Location: Danvers, MA-01923 [On-site] Job Description: 5+ years industry experience in Information Security.Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR).Experience with security risk management techniques.Demonstrated organizational skills, attention to detail, the ability to handle multiple assignments simultaneously in a timely manner and be able to meet assigned deadlines.Co

Quality Management Systems (QMS) and Cybersecurity Compliance SpecialistJob Title - Quality Management Systems (QMS) and Cybersecurity Compliance Specialist

Dew SoftwareCompany Name - Dew Software

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Massachusetts, USA

Third Party, Contract

Job Description: Seeking a skilled Quality Management Systems (QMS) and Cybersecurity Compliance Specialist to lead the integration and upgrade of our QMS, assist in internal cybersecurity audits, and provide regulatory submission support (FDA, EU) at our Boston site. The ideal candidate will bring a comprehensive understanding of quality management processes, document control, and corrective and preventive actions (CAPA), with experience supporting regulatory compliance initiatives. Key Respon

Embedded Test Engineer (Bluetooth Protocol tools Sodera, nRF sniffers, Power Analyzer tools)Job Title - Embedded Test Engineer (Bluetooth Protocol tools Sodera, nRF sniffers, Power Analyzer tools)

Cigniti Technologies IncCompany Name - Cigniti Technologies Inc

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Acton, Massachusetts, USA

Full-time

Job details: Job Role: Embedded tester (Bluetooth Protocol tools Sodera, nRF sniffers, Power Analyzer tools) Location: Acton, MA Must Have Skill sets:experience in Embedded device /Hardware Testing knowledge Ability to perform whitebox testing, unit testing Hands on experience in mobile app or mobile device testing. Hands on experience in Python/Appium is added advantage. Experience on working, Test Hardware and boards Perform end-to-end functional testing and validation for the application

Sr. QA ManagerJob Title - Sr. QA Manager

Zachary Piper Solutions, LLCCompany Name - Zachary Piper Solutions, LLC

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Chelmsford, Massachusetts, USA

Full-time

Piper Companies is seeking a Senior Quality Assurance Manager to lead quality assurance efforts for a medical device facility in Chelmsford, MA through a M-F Onsite work schedule. The Senior Quality Assurance Manager is pivotal in ensuring compliance with regulatory standards and driving continuous improvement initiatives. Responsibilities of the Senior Quality Assurance Manager include: Lead quality assurance for two products: balloon pump and balloon catheter. Develop and execute QA strategie

Reliability EngineerJob Title - Reliability Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Danvers, Massachusetts, USA

Full-time

Responsibilities: Develop and implement reliability test plans and protocols. Conduct Failure Mode and Effects Analysis (FMEA) and Root Cause Analysis. Perform statistical analysis and reliability data analysis. Collaborate with cross-functional teams to ensure design for reliability (DfR) principles are integrated into product development. Conduct accelerated life testing (ALT) and Weibull analysis. Ensure compliance with regulatory standards (FDA, ISO 13485). Develop and maintain reliability

Validation Engineer, Sterile & CleaningJob Title - Validation Engineer, Sterile & Cleaning

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Bedford, Massachusetts, USA

Full-time

Responsibilities: We are seeking an experienced Sterile & Cleaning Validation Engineer to support validation activities within a medical device manufacturing environment. The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently. This role involves performing revalidation tasks for equipment and working closely with cross-functional teams. Develop and execute

Medical Devices Product Security EngineerJob Title - Medical Devices Product Security Engineer

Laiba Technologies LLCCompany Name - Laiba Technologies LLC

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Danvers, Massachusetts, USA

Contract, Third Party

Role: Product Security EngineerLocation: Danvers, MA-01923 [On-site] Security risk management techniquesRegulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR)Pre-market product development activitiesMedical devicesFDA 5+ years industry experience in Information Security. Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR). Experience with security risk managem

Product Security EngineerJob Title - Product Security Engineer

Octigo Solutions IncCompany Name - Octigo Solutions Inc

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Danvers, Massachusetts, USA

Contract, Third Party

Title: Product Security Engineer Location : Danvers, MA ( day 1 onsite) Duration: Longterm 4 Positions to fill Note- Cybersecurity experience in medical device / domain is mandatory Job description 5+ years industry experience in Information Security.Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework, ISO27001, SOC2, HIPAA, GDPR).Experience with security risk management techniques.Demonstrated organizational skills, attention to detail, the ab

Cyber Security EngineerJob Title - Cyber Security Engineer

Octigo Solutions IncCompany Name - Octigo Solutions Inc

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Danvers, Massachusetts, USA

Contract

Title: Product Security Engineer-4 Positions to fill Location : Danvers, MA ( day 1 onsite) Note- Cybersecurity experience in medical device / domain is mandatory Job description 5+ years industry experience in Information Security. Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR). Experience with security risk management techniques. Demonstrated organizational skills, attention to detail, the ability to hand

Product Cybersecurity EngineerJob Title - Product Cybersecurity Engineer

Sureminds SolutionsCompany Name - Sureminds Solutions

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Danvers, Massachusetts, USA

Contract

Please share Profiles at Hi, Urgent need, Title: . Product Security Engineer- Location : Danvers, MA ( day 1 onsite) Note- Cybersecurity experience in medical device / domain is mandatory Job description 5+ years industry experience in Information Security. Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR). Experience with security risk management techniques. Demonstrated organizational skills, attention to deta

Software Engineer IVJob Title - Software Engineer IV

OnPoint Surgical, Inc.Company Name - OnPoint Surgical, Inc.

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Concord, Massachusetts, USA

Full-time

The Software Engineer will develop medical device software for surgical planning and intra-operative guidance of spinal procedures, including spinal fusion, as part of a computer-aided surgery system for medical device start-up. They should possess expert-level proficiency in C# and have a deep understanding of software engineering principles, including object-oriented design, data structures, algorithms, and software architecture. As well as skilled in developing and debugging software that in

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Framingham, Massachusetts, USA

Full-time

Responsibilities: Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP. Preparing trace matrix to ensure requirements are tested to meet the software intended use. Preparing risk assessment for functional requirements and providing testing. strategy, implementing technical & procedural controls as part of mitigation. Preparing SOP/Work instruction for equipment and software-based systems. Requirements: 6 to 8 years of Non-Product Software