ISO 13485 jobs in Danvers, MA

Sr. Supplier Quality Engineer (ONLY W-2 role)

Bedford, Massachusetts

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13d ago

Position Title: Sr. Supplier Quality Engineer (PHIAJP00004186) Location: Bedford MA Duration: 12 months Positions Requested: 2 Hours per Week: 40 (8 hrs/day) Notes from the manager: Major focus in experienced Process Validation, Verification across plastic, metal and electronics along with problem solving for candidates to support +700 parts for part qualification for Spectrawave products. The product contains Catheter and Console (System) products. Manufacture engineering, Product Quality, and/

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Contract

50 - 55

Litigation Associate (Complex Business)

Boston, Massachusetts

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Today

Medical Device Leader! Principal Quality Engineer Opportunity! This Jobot Consulting Job is hosted by: David DeCristofaro Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $65 - $85 per hour A bit about us: We are a leading medical device company that operates privately and is committed to enhancing the care and quality of life of patients with kidney disease. Our goal is to create cutting-edge solutions that enable patients and their healthcare

Full-time

Compensation information provided in the description

Senior Product Quality Engineer, Industrials

Newburyport, Massachusetts

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Today

About Us Founded in 2015 to develop the world's first industrially scalable laser metal additive manufacturing solution, VulcanForms is reshaping how the world manufactures critical products. We build and operate advanced digital infrastructure that enables innovation, accelerates growth, and supports sustainability across aerospace, defense, medical, and other essential industries. Through our vertically integrated capabilities, including scalable additive manufacturing and precision machining

Full-time

USD 96,000.00 - 132,000.00 per year

Lead Product Quality Engineer, Industrials

Newburyport, Massachusetts

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Today

Full-time

USD 117,400.00 - 161,500.00 per year

Validation Engineer

Boston, Massachusetts

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Today

Job Summary: We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements. Experience with infusion pump systems or similar electromechanical medical devices is preferred. Roles & Responsibilit

Full-time

Senior Software Quality Assurance Engineer

Andover, Massachusetts

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Today

Job Description As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end design quality and compliance across the product development lifecycle for Class II/ medical devices, including software-driven and active implantable products. Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commerc

Full-time

Product Design Quality Engineer

Cambridge, Massachusetts

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Today

Job Description: The Product Design Quality Engineer is responsible for supporting quality throughout the product development lifecycle by ensuring compliance with regulatory requirements, quality standards, and design control processes. This role partners with cross-functional teams to integrate quality into product development, risk management, validation, and manufacturing transfer activities. Responsibilities: Support Design Control activities throughout the product development lifecycle in

Full-time

Drug Delivery Test & Evaluation Engineer

Boston, Massachusetts

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Today

Job Title: Senior R&D Engineer, Drug Delivery Systems (Test & Evaluation) Role Overview We are seeking a hands-on Drug Delivery Test & Evaluation Engineer to join a multidisciplinary R&D team dedicated to pioneering innovative delivery systems. In this role, you will apply core engineering and scientific principles to evaluate the performance of formulation and device prototypes. You will be responsible for the end-to-end testing lifecycle-from designing custom experimental setups to executing

Full-time

USD 158,100.00 - 158,100.00 per year

Manufacturing Technician I

Lawrence, Massachusetts

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2d ago

Client LocationCountry: United StatesState/Province: MassachusettsCity: LawrenceAddress: 360 Merrimack Street, Lawrence*LawrencePOSTAL CODE: 01843Duties: Execute consumables manufacturing processes according to established Standard Operating Procedures (SOPs) Maintain strict adherence to quality standards and efficiency metrics Operate in cleanroom environments following contamination control protocols Handle consumable materials with precision under guidance of Group Leaders or trai

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Contract, Third Party

$25 - $25

Principal Engineer, Mechanical Engineering

Wilmington, Massachusetts

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Today

About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centers. With revenue of more than $11 billion in FY25, ADI ensures today's inno

Full-time

USD 157,080.00 - 227,460.00 per year

Engineer, Quality Engineering

Wilmington, Massachusetts

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Today

Full-time

USD 75,200.00 - 103,400.00 per year

Imaging Service Engineer I (Boston, MA)

Boston, Massachusetts

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Today

Position Overview An Imaging Service Engineer I is responsible for performing scheduled service work on systems within a service area, and some unscheduled work in the service area with the assistance of technical support, as directed by the Area Service Manager. Company Overview At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagno

Full-time

USD 32.69 - 38.46 per hour

Senior Engineer, Quality Engineering

Wilmington, Massachusetts

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Today

Full-time

USD 95,600.00 - 131,450.00 per year

Senior Systems Test Engineer - Electrophysiology

Waltham, Massachusetts

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Today

Additional Location(s): US-MN-Arden Hills Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing -

Full-time

USD 89,200.00 - 169,500.00 per year

Software Architect

Bedford, Massachusetts

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Today

Our client is a global leader in medical diagnostics, developing innovative technologies that support hospitals, laboratories, and healthcare providers around the world. With decades of industry leadership and a strong commitment to research and development, the company continues to invest in next-generation diagnostic platforms that improve patient care through advanced software and instrumentation. This is an outstanding opportunity for an experienced Software Architect to join a highly collab

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Full-time

$175000 - $225000

Associate Technical Project Manager

Acton, Massachusetts

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Today

Job#: 3045356 Job Description: Apex Systems is a world-class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients' digital visions. Apex has an opportunity for a Associate Technical Project Manager. Interested candidates can send an updated resume to Dan Hornby, Account Manager, at . Here are the details: Position: Associate Technical Project Manager Location: Acton, MA Hybrid to Acton, MA. Onsite expectations: Up to 1

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Full-time

$48 - $52 per hour

Senior Embedded Firmware Engineer

Wilmington, Massachusetts

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Today

Who is Re:Build Manufacturing? At Re:Build, our mission is to ensure the next generation of important products are made, at scale, in America. We are laying the foundation for a better future for our customers, employees, and communities by revitalizing America's manufacturing base and creating meaningful jobs across the country, including in historically deindustrialized regions. We operate an advanced, end-to-end manufacturing platform that partners with industrial companies and innovators t

Full-time

USD 143,666.72 - 215,500.08 per year

Senior Product Quality Engineer

Danvers, Massachusetts

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Today

Senior Product Quality Engineer Location: On-site in Danvers, MA Who We Are Samsung HME America (Healthcare and Medical Equipment) is Samsung's U.S. medical imaging organization, delivering advanced diagnostic solutions across Ultrasound, Digital Radiography, and Computed Tomography. We lead nationwide sales, marketing, service, and distribution of Samsung's imaging technologies, partnering with healthcare providers to strengthen diagnostic capabilities, streamline clinical workflows, and suppo

Full-time

USD 120,000.00 - 150,000.00 per year

Auditor

Remote or Chicago, Illinois

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Yesterday

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems

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Full-time

$40.0000 - $43.0000

Sr Staff Device Engineer

Lexington, Massachusetts

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Today

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 About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformativ

Full-time

USD 137,000.00 - 215,270.00 per year

ISO 13485 jobs in Danvers, MA 01923, USA