- NIOX (Chicago, IL)
- NIOX is a medical device company focused on point of care asthma diagnosis and management. Our market-leading NIOX(R) products are used in clinical settings by ... in Life Sciences or Business Administration Minimum 2 years' experience medical device /supplies selling, along with prospective customer relationship development… more
- Wolters Kluwer (Riverwoods, 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)
- …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 (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
- AbbVie (North Chicago, IL)
- …Third Party Manufacturers. + Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...resource needs at each site and provide guidance on quality concerns. + Communicates and negotiates with external… 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
- 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
- Actalent (Morton Grove, IL)
- …projects in support of corrective, preventive and improvement actions Skills medical device manufacturing, iso13485, CAPA's, investigations, six sigma, flexible ... Description MANUFACTURING QUALITY ENGINEER * Quality System Duties:...packaging, bilingual Top Skills Details medical device manufacturing,iso13485,CAPA's,investigations Additional Skills & Qualifications… 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
- Lilly (Pleasant Prairie, WI)
- …computer science-related field preferred + Minimum 5 years working in the pharmaceutical or medical device industry in QA roles + Minimum 3 years of experience ... expert to facilitate and drive improvements in M&Q data-related corporate quality standards, business processes, organizational design, and governance necessary for… 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
- 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
- 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
- AbbVie (North Chicago, IL)
- …+ BS in Mechanical Engineering with 12+ years of experience, ideally in the medical device and / or pharmaceutical industries; MS with 10+ years of ... interactions with CMC drug products, analytical efforts, regulatory requirements, quality standards, operations, external customers, users, contract… more
- Edwards Lifesciences (Chicago, IL)
- …+ Knowledge of cardiovascular physiology and structural heart anatomy + Previous medical device Clinical Research experience in cardiology + Clinical research ... and physiology or Business Unit area of expertise + Moderate understanding of medical device regulatory requirements and documents, device accountability and… more
- Edwards Lifesciences (Chicago, IL)
- …for (Preferred):** + Deep engineering experience, with a strong background in medical device development. Experience in implantable sensors for cardiac ... principles and practices + Knowledge and understanding of relevant medical device regulations (21 CFR Part 820),...technical briefings for senior and top management and for external representatives + Frequently involve special skills, such as… more
