FDA Jobs in Boston, MA

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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

•

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 8 days ago | Updated 2 days ago

SW TEST ENGINEER

Echo IT Solutions, Inc.

•

Cambridge, Massachusetts, USA

Contract

Job Title: SW TEST ENGINEER Job Duration: Long Term Contract Role Location: Cambridge, MA (Onsite Role) Key skills required for this role: Experience with Microsoft Windows and Linux operating systems Embedded device testing Testing real-time large-scale distributed client-server applications Developing regression and/or functional test suites Knowledge of FDA regulations (IEC 62304, 21 CFR Part 820) TCP/IP and Cisco equipment/configurations Understanding of 802.11 wireless technologies and RF
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Posted 8 days ago | Updated 10 hours ago

Staff Software Engineer

Connexion Systems & Engineering

•

Methuen, Massachusetts, USA

Full-time

Title: Staff Software Engineer Hiring Organization: Connexion Systems & Engineering Compensation, Benefits, and Employment Type Duration: Direct HirePay rate: $120k-$155k annuallyJob Location: Methuen, MASchedule: hybrid (3 onsite, 2 remote), M-F, standard business hoursJob#: bh17292 Ideal Candidate Profile: The ideal candidate will have broad-spectrum experience in embedded and application development in the medical device industry, experience writing technical requirements (TSSR), strong skil
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Posted 60+ days ago | Updated 1 day ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

•

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 60+ days ago | Updated 4 hours ago

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

Amerit Consulting

•

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 10 days ago | Updated 1 day 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 26 days ago | Updated 1 day 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 2 days ago | Updated 2 days ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

•

Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and
Posted 8 days ago | Updated 10 hours ago

Senior Mechanical Engineer - Med Device

Motion Recruitment Partners, LLC

•

Boston, Massachusetts, USA

Full-time

Our client, an established global leader in the diagnostics and medical device sector, is currently seeking a Senior Mechanical Engineer to join their growing R&D team. This role offers the opportunity to work on advanced diagnostic instruments and devices that directly impact patient care and clinical outcomes. Key Responsibilities: Lead the design and development of mechanical components and subsystems for complex medical devices, from concept through to production.Collaborate with cross-fun
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Posted 1 day ago | Updated 18 hours ago

Software Verification Engineer

Katalyst Healthcares and Lifesciences

•

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
Posted 8 days ago | Updated 10 hours ago

Validation Engineer, Sterile & Cleaning

Katalyst Healthcares and Lifesciences

•

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
Posted 24 days ago | Updated 10 hours ago

Software Engineer IV

OnPoint Surgical, Inc.

•

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
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Posted 26 days ago | Updated 26 days ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Waltham, Massachusetts, USA

Full-time

Responsibilities: Independently perform validation activities including installation qualification, operational qualification, performance qualification for Base Camp projects related to facility, utilities, equipment and instrument. Generate protocols for tests, verification, and qualification for GxP assets, as well as reports to document execution. Ensure deliverables meet the overall facility milestones. Perform and support periodic assessment review and revalidation activities. Ensure deliv
Posted 24 days ago | Updated 10 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Boston, Massachusetts, USA

Full-time

Responsibilities: Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards. Design validation approaches, supported by appropriate statistical analyses, perform and/or coordinate all validation activities, analyze and assemble results, and draft validation reports. Perform Data Integrity Assessments and review s
Posted 24 days ago | Updated 10 hours ago

Software QA Engineer

Judge Group, Inc.

•

Newton, Massachusetts, USA

Full-time

Location: Newton, MA Salary: $45.00 USD Hourly - $48.00 USD Hourly Description: Our client is currently seeking a Software QA Engineer This job will have the following responsibilities: We are currently looking for an ambitious Software QA Engineer to join our Endovascular Robotics business within Advanced Therapies. We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics, image guidance and dedicated devices will ch
Posted 5 days ago | Updated 6 hours ago

Lead Engineer, Quality Validation

Katalyst Healthcares and Lifesciences

•

Andover, Massachusetts, USA

Full-time

Job Description: The contract Lead Engineer, Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to laboratory instruments, temperature control units and LFH/BSC units for internal customers. The individual will support and facilitate the review and approval of qualification/validation documentation for all stages of the equipment life cycle qualification process. Responsibilities: Provide quality oversight of Bl
Posted 24 days ago | Updated 10 hours ago

Sr. Quality Assurance Manager - Manufacturing/Med Device

Zachary Piper Solutions, LLC

•

Chelmsford, Massachusetts, USA

Full-time

Piper Companies is hiring a Senior Manager of Quality Assurance (Manufacturing/Medical Device) for a medical device company located in Chelmsford, MA. The Senior Manager of Quality Assurance (Manufacturing/Medical Device) will oversee QA Operations, derive continuous improvement initiatives and foster a culture of quality across the organization. The Senior Manager of Quality Assurance (Manufacturing/Medical Device) will need to work onsite 5 days per week in Chelmsford, MA. Responsibilities fo
Posted 8 days ago | Updated 7 hours ago

Senior Automation Engineer

Merck KgaA

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Bedford, Massachusetts, USA

Full-time

Work Location: Bedford, Massachusetts Shift: No Department: LS-PS-RSL Legacy & Acquired Technology Development Recruiter: Stefanie Fried This information is for internals only. Please do not share outside of the organization. Your Role Design of the SCADA software: Drive the software release projectsParticipate in architecture reviews with the Architect and Expert. Ensure modifications to come are in line with the team purposes.Challenge the vision to ensure guarantee its feasibility with the
Posted 8 days ago | Updated 10 hours ago

Product Manager - Medical Devices

Motion Recruitment Partners, LLC

•

Marlborough, Massachusetts, USA

Full-time

A medical device manufacturer and distributor in Marlborough is looking for talented Product Managers to join their team. They recently launched a novel FDA approved medical device that is being used to treat impulse control, addiction, and depression. This product has the potential to be revolutionary in the mental wellness space. They are looking for Product Managers who hav a strong background in medical device product management with a background either in biology or biomechanical engineeri
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Posted 47 days ago | Updated 18 hours ago

Senior ALM Administrator

Kforce Technology Staffing

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Remote or Acton, Massachusetts, USA

Contract

RESPONSIBILITIES: Kforce has a client in Acton, MA that is seeking a Senior ALM Administrator to manage, support, and enhance our R&D Application Lifecycle Management (ALM) tools-Helix and Polarion. The Senior ALM Administrator will play a key role in data migration, configuration, system integration, and user support to ensure efficient, compliant, and high-quality product development. Responsibilities: * Administer and configure ALM systems (Helix, Polarion) * Lead data migration and system i
Posted 15 days ago | Updated 3 hours ago