- 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
- 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
- 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
- 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 (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
- 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
- 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 (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
- 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
- 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
- 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
- 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
- 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 (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
- 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
- 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
- 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
- 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 (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
- Abbott (Buffalo Grove, IL)
- …in Medical Device industry + Minimum of 4-6 yrs of experience in a Quality role in Medical Device industry + Substantial knowledge of FDA and ISO ... manufacturing including yield and quality data reports, finished device acceptance, validation, external inspections, incoming, equipment calibration and… more