• Medical Device External

    AbbVie (North Chicago, IL)
    …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Manager, Medical Device External Quality is part of ... and Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality . The role will be based out of Lake… more
    AbbVie (03/18/25)
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  • Director CMC Development (PRTL) Packaging…

    Astellas Pharma (Northbrook, IL)
    **Director CMC Development PRTL Packaging & Device US** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every ... countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping… more
    Astellas Pharma (05/01/25)
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  • Product Surveillance Tech I ( Medical

    US Tech Solutions (North Chicago, IL)
    **JOB SUMMARY:** + Under general direction, the **Post Market** Quality Assurance (PMQA) Analyst I will investigate and maintain **complaint files,** in compliance ... and skill sets. + Provides technical and administrative support to internal and external customers. " + The candidate must conduct their work activities in… more
    US Tech Solutions (04/18/25)
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  • Associate Director, External Manufacturing…

    AbbVie (North Chicago, IL)
    …Strong strategy development and planning skills coupled with necessary knowledge of Medical Device or Combo Product development, manufacturing and supply ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...experience, in areas such as: Manufacturing, Engineering, Project Management, Quality and PDS&T. + In plant device more
    AbbVie (06/07/25)
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  • Director, External Manufacturing

    AbbVie (North Chicago, IL)
    …for Medical Devices or Combination Products. Assure that high quality products are manufactured in compliance with local and international regulations, and ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...Quality expectations. + Lead the development of ECM Device Financial Operating Plan, Updates, LRP, and Standard processes,… more
    AbbVie (04/23/25)
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  • Senior Manager, Clinical Product Quality

    Edwards Lifesciences (Naperville, IL)
    … related field plus a minimum of 8 years of relevant experience. + Medical device industry, quality systems, or hospital/clinical experience (eg cath ... lab, cardiac care, ICU, OR, or cardiovascular/endovascular interventions). Combination of nursing, quality and/or medical device industry experience is a… more
    Edwards Lifesciences (05/23/25)
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  • Senior Director, Quality , Digital

    GE HealthCare (Chicago, IL)
    …experience interfacing with regulators. + Experience working and communicating directly with external medical device regulators. We expect all employees ... maintain systems, rules, and processes to ensure fulfillment of internal and external quality requirements. Specifically, working closely with the business to… more
    GE HealthCare (05/20/25)
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  • Director, Product Quality

    AbbVie (North Chicago, IL)
    …AbbVie or third-party manufacturer Intermediates/Drug Products. Acts as the principle, quality , global supply chain rep. with external manufacturing businesses. ... medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's… more
    AbbVie (05/03/25)
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  • Associate Director, Product Quality

    AbbVie (North Chicago, IL)
    …the management of exception documents and CAPA. + Communicates and negotiates with external companies' quality organization to maintain a consistent level of ... medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's… more
    AbbVie (04/23/25)
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  • Lead Quality Engineer, Production…

    GE HealthCare (Chicago, IL)
    …available. **Desired Characteristics** + Good understanding and knowledge of local and global Medical Device QMS regulations and standards such as but not ... **Job Description Summary** This position will support the Chicago Quality Organization by supporting digital manufacturing and distribution controls....ISO 13485, EU MDR. + Experience with Software as Medical Device (SaMD) and Medical more
    GE HealthCare (05/16/25)
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  • Quality Engineer II

    Edwards Lifesciences (Naperville, IL)
    …requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. **How ... of statistical techniques * Previous experience working with FDA regulated industry ( medical device experience highly preferred) Working knowledge of ISO 13485,… more
    Edwards Lifesciences (05/08/25)
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  • Manager, Design Quality Lifecycle…

    AbbVie (North Chicago, IL)
    …CQE, SSBB, etc.) + 8+ years of relevant experience in the medical device industry; at least 5+ years in Quality Assurance experience required. + Working ... assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical ...SME. + Participate in the development of global Product Quality Assurance strategy to support device and… more
    AbbVie (05/22/25)
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  • Senior Quality Engineer, Reader

    Edwards Lifesciences (Naperville, IL)
    device industry, preferably with electromechanical devices and medical device software * ASQ Certified Quality Engineer * Technical writing skills, ... will make an impact:** As a member of the Quality Team, the Quality Engineer will review...technically sound and sufficient given level of risk and internal/ external requirements. + Review risk analyses and design and… more
    Edwards Lifesciences (05/16/25)
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  • Senior Engineer, Quality - Lifecycle…

    AbbVie (North Chicago, IL)
    …or other technical areas. + 6+ years of relevant experience in the medical device industry; 4+ years of Quality Assurance experience required. + 6+ years of ... etc. Responsibilities + Perform QA activities related to Combination Product and Medical Device Design Transfer and Change Management: + Ensure compliance… more
    AbbVie (05/22/25)
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  • Associate Director, Design Quality - Late…

    AbbVie (North Chicago, IL)
    … elements needed to facilitate new product introductions of combination products and medical devices. + Develops Global Product Quality Assurance strategy and ... support the development of NPI projects. + Makes key decisions on product quality , compliance and regulatory conformance issues for medical devices and… more
    AbbVie (05/19/25)
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  • Lead Quality Analyst

    GE HealthCare (Arlington Heights, IL)
    …degree (or high school diploma/GED plus 4 years experience in a QA/RA or medical device /pharmaceutical environment) + 1+ year of experience in a medical ... **Job Description Summary** GE HealthCare is a medical technology and diagnostics business with a vision to become the leading innovator enabling precision health.… more
    GE HealthCare (05/13/25)
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  • Commercial Quality Manager

    Abbott (Des Plaines, IL)
    …+ Provide Quality leadership in direct support of Invitro Diagnostic & medical device Distribution and Commercial Quality . + Management and development ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
    Abbott (05/01/25)
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  • Job Description Medical Science Liaison…

    Abbott (Abbott Park, IL)
    …of 6-10 years of clinical/ medical affairs experience, preferably in medical device industry + Understanding of the clinical laboratory, assay/instrument ... Regulatory Affairs, and/or Medical Communications experience in the diagnostics/ medical device /pharmaceutical industry is preferred. + Influence and lead… more
    Abbott (05/15/25)
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  • Supplier Quality Engineer I

    Edwards Lifesciences (Naperville, IL)
    quality management, quality engineering, or manufacturing engineering within the medical device industry or another regulated industry + Ability to ... (or applicable e-QMS system) + Comply with internal and external quality requirements for supplier management +...for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination… more
    Edwards Lifesciences (05/23/25)
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  • Field Clinical Specialist, Chicago Northwest

    Terumo Medical Corporation (Chicago, IL)
    …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications ... drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
    Terumo Medical Corporation (03/21/25)
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