- 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
- Medline (Winnetka, IL)
- Job Summary Under broad supervision, responsible for independently setting basic quality standards for both in-process while leading efforts to develop methods for ... changes. Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports… more
- Michael Page (Mundelein, IL)
- …Experience dealing with the FDA IQ/OQ/PQ experience Background in pharmaceutical, medical device , or food packaging manufacturing Sponsorship not provided ... consistent growth in recent years and is now seeking to add a Senior Quality Manager to their team. Their primary customers include clinics and pharmacies. Job… 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...the manufacturing agreement in accordance with Purchasing and Supplier Quality expectations. Lead the development of ECM Device… more
- BioSpace (North Chicago, IL)
- …industry experience (at least 4 years) with sufficient exposure to pharmaceutical, medical device , biologics and combination products, cosmetics, eye care or ... Quality Assurance with some project management experience in the pharmaceutical, medical device , biotechnology or related industry and 2+ years in… more
- Wolters Kluwer (Chicago, IL)
- …and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external standards. **QUALIFICATIONS** **Education:** ... on-market medical devices including Software as a Medical Device (SaMD) within the Health Division...in existing processes and develop new processes. + Support external and internal audits; represent Quality Assurance… 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)
- …and deliver a comprehensive risk management program for pharmaceutical, combination and medical device products across the company. Chair and charter governance ... and strategic initiatives. Manages the interrelated functional activities related to medical device and pharmaceutical products including design control.… more
- AbbVie (North Chicago, IL)
- …to the overall success of drug/ device development programs. Associate Director, Safety, Medical & Regulatory Quality is part of the R&D Quality ... Medical Affairs (MA) QA team which provides independent quality oversight of AbbVie's Medical Affairs and...activities. The role covers AbbVie's entire portfolio of drug, device and cosmetics. The role ensures quality … 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
- Edwards Lifesciences (Naperville, IL)
- …requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. **How ... Applies knowledge of quality engineering principles and methods to ensure compliance...techniques * Previous experience working with FDA regulated industry ( medical device experience highly preferred) Working knowledge… 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)
- …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 (North Chicago, IL)
- … Assurance, Regulatory, Operations, or Technical Support in a pharmaceutical or medical device setting required. Experience working in a regulatory agency ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...Compliance Excellence uses advanced subject matter expertise of global quality standards, cGMP, and external agency regulations… more
- Mallinckrodt Pharmaceuticals (Chicago, IL)
- …Engineering, Science, or a related field + 7+ years of experience in the medical device and pharmaceutical industry + Strong knowledge and in-depth understanding ... quality issues, implementing sustainable corrective actions + Support internal/ external audits and regulatory inspections, ensuring consistent compliance + Design… more
- Edwards Lifesciences (Naperville, IL)
- …(Preferred):** + Medical device experience preferred, including familiarity with medical device regulations and quality standards (eg, FDA, ISO) and ... for suppliers. + Device Performance Monitoring: Continuously monitor and assess device performance and quality metrics. Develop and execute plans to address… more
- Abbott (Abbott Park, IL)
- …inspection support. This support encompasses FDA inspections for the Nutrition, Medical Device , Diagnostics, and Pharmaceutical sectors within Abbott. **What ... Program Manager is to provide leadership, oversight, and project management covering external inspections as related to Abbott's Quality System. This includes… more
- Jabil (Gurnee, IL)
- …short shots, color variation, voids, and grease/oil. Verifies packaging and labeling quality and integrity.- Responsible for reviewing device history records ... for inspecting products at various stages of the production process to maintain quality and reliability of products in accordance with required quality plans.… more
