ISO 13485 jobs in Wisconsin

Quality Manager - Medical Device/ ISO 13485

Salem Lakes, Wisconsin

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Today

Description: Quality Manager | ISO 13485 Medical Device Manufacturing We are seeking a hands-on Quality Manager who can lead and continuously improve our ISO 13485 Quality Management System while supporting a fast-paced medical device packaging manufacturing operation. This individual will serve as the site quality leader, partnering closely with Operations, Engineering, Supply Chain, and Customer Service to ensure compliance, drive continuous improvement, and maintain customer confidence. The

Full-time

USD 95,000.00 - 125,000.00 per year

Auditor

Remote or Chicago, Illinois

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Today

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

Quality Technician

Appleton, Wisconsin

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Today

Quality Technician Responsible forassuring all customer and company quality expectations are being satisfied atall manufacturing and inspection process steps. Identify and implementcontinuous quality improvement activities. Provides directions to qualityinspectors. Helps with containments ofproduct and root cause investigations. Escalates problems to management and make recommendations for solutions. Who are we? Founded in 1849, Ducommun is the oldest company in California. Starting as a hardw

Full-time

Senior Systems Engineering Compliance Engineer

Madison, Wisconsin

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Today

Give hope. Give health. Make your mark in the fight against cancer. At Accuray, we make a direct and powerful impact on the lives of cancer patients every day - helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer - helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world.

Full-time

Service Engineer - BMH

Madison, Wisconsin

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Today

Job Description Summary About the Team GE HealthCare's Bone and Metabolic Health business designs, manufactures, and supports the Lunar family of dual-energy X-ray absorptiometry (DXA) and body composition systems used worldwide to diagnose osteoporosis, assess fracture risk, and monitor metabolic health. Our Service organization relies on accurate field data and clear technical communication to keep this fleet running reliably and to continuously improve our products. Role Summary This Lead

Full-time

Backend AI Engineer - Remote

Remote or San Diego, California

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Today

Genesis10 is currently seeking a Backend AI Engineer - Remote for a contract position with a Global Medical Technology Company located in San Diego, CA. This is a 12+ month contract opportunity. This position is 100% remote. Compensation: $43.00 - $53.00 per hour, W2, based on qualifications Position Overview: This role focuses on developing and implementing generative AI solutions, including building robust RAG pipelines, fine-tuning LLMs, and creating high-performance APIs. The ideal candidat

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Full-time

Compensation information provided in the description

Senior Staff Software Advance Quality Engineer

Remote or Detroit, Michigan

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Today

Work Flexibility: Remote or Hybrid or Onsite It's Time to Join Stryker! Why Join Us In this role, you will help shape software quality practices across a growing portfolio of digital and connected solutions. You will influence how software teams incorporate quality, compliance, security, and risk management into development while establishing scalable processes that support innovation and efficient delivery. Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our

Full-time

USD 102,600.00 - 171,000.00 per year

Staff Software Engineer

Remote or California

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Today

The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team me

Full-time

USD 140,000.00 - 160,000.00 per year

Senior Account Manager- Medical Devices

Remote

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Today

Req ID: 137305 Remote Position: Yes Region: Americas Country: USA Summary Celestica is dedicated to delivering end-to-end product lifecycle solutions to drive our customers' success. Our growing Advanced Technology Solutions (ATS) organization focuses on applying Celestica's advanced capabilities, knowledgeable people and innovative tools to enable companies in the medical device industry with highly complex, mission critical applications to improve their competitive advantage. We are current

Full-time

USD 123,000.00 - 163,000.00 per year

Principal Engineer, Customer Quality

Remote

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Today

Littelfuse (NASDAQ: LFUS) is a diversified industrial technology manufacturing company shaping solutions for the safe and efficient transfer of electrical energy. Headquartered in Chicago, Illinois, USA, we serve customers across industrial, transportation, and electronics markets worldwide. With approximately 16,000 employees we design and manufacture innovative technologies that support electrification, energy efficiency, and advanced automation. Our global reach is matched by a culture that e

Full-time

USD 123,100.00 - 190,780.00 per year

Senior Database Design Engineer

Remote

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Today

Full-time

USD 100,000.00 - 120,000.00 per year

Principal HL7 Integration Engineer

Remote

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Today

Position Overview The Principal HL7 Integration Engineer oversees all technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. The Principal HL7 Integration Engineer must have expert level knowledge in all areas of medical informatics, IT infrastructure design and deployment, medical imaging industry in general and clinical environment workflow. In addition to technical expertise, HCUS relies on Th

Full-time

USD 110,366.00 - 140,000.00 per year

Medical Device V&V engineers

Remote or New Jersey

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Today

Summary: We are seeking highly skilled and experienced System Engineers to join our team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation. This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle. Roles & Responsibilities: Design Controls: Lead efforts to deve

Full-time

Technical Sourcing Mechanical Engineer III

Madison, Wisconsin

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Title: Technical Sourcing Mechanical Engineer (TSE) How will you make an impact? The Staff Technical Sourcing Engineer (TSE) plays a pivotal role in our Global Value Assurance Organization. You will determine strategies for cost savings, cost avoidance, and revenue generation, while strictly ensuring risk mitigation and supplier quality. Your contributions will enable us to continue delivering world-class

Full-time

Senior PLM Windchill Solution Architect

Remote

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4d ago

Position OverviewWe are looking for aSenior PLM Windchill Solution Architectto lead a strategic, customer-facing PLM engagement for a leadingMedical Device / Life Sciences organization.The ideal candidate will be a senior techno-functional architect with strongPTC Windchill PLMexpertise and experience owning end-to-end architecture, technical governance, integrations, migration, validation, AMS, and customer stakeholder management.Key ResponsibilitiesLead end-to-endPTC Windchill PLM solution arc

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Contract

80 - 90

Senior Software Design Assurance (Sr Software Design Quality) Engineer

Remote

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Today

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insig

Full-time

USD 95,900.00 - 159,900.00 per year

SAP Digital Manufacturing (DM) Consultant

Madison, Wisconsin

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Today

Job Title Python API Developer Skill Digital : Python Skill Type Marketable Minimum Experience 10 - 15 Years Qualification BACHELOR OF COMPUTER SCIENCE Location Malvern, PA a { text-decoration: none; color: #464feb; } tr th, tr td { border: 1px solid #e6e6e6; } tr th { background-color: #f5f5f5; } Mandatory Technical Skills Python Development AWS Lambda (Serverless Architecture) REST API Development Amazon Aurora Database DynamoDB Liquibase (Database Migrations & Version Control) Key Responsi

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Contract, Third Party

Engineer I, Software Quality

Remote

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Today

Position Overview This position is intended to be an entry level position focused on software functional testing and quality assurance, and the fulfillment of relevant procedure and documentation per Fujifilm Medical Informatics Design Control process for software development. 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 soluti

Full-time

SAP QM Architect

Remote

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26d ago

SAP QM ArchitectThe SAP Quality Management (QM) Architect leads the design, implementation, and optimization of SAP QM solutions in a regulated medical device manufacturing environment. The role requires deep expertise in QM processes, strong cross-module integration skills, and hands-on experience across implementations, rollouts, and upgrades. The architect ensures quality processes meet FDA/ISO standards and seamlessly integrate with manufacturing, supply chain, and compliance systems. Respon

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Contract

Depends on Experience

Senior Generative AI Engineer (Google Gemini & Vertex AI) - Remote

Remote

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6d ago

DivIHN (pronounced divine) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent. Visit us at to learn more and view our open positions. Please apply o

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Third Party, Contract

$51 - $55

ISO 13485 jobs in Wisconsin, USA