- Tecomet (Kenosha, WI)
- **Sr. Quality Assurance & Regulatory Affairs Manager** **POSITION SUMMARY** The Sr. Quality and Regulatory Manager will provide overall company ... leadership and direction for Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. Objectives… more
- AbbVie (North Chicago, IL)
- …such as analytical, process engineering, internal and external manufacturing, quality assurance , CMC regulatory affairs , supply chain and Operations ... development reports or risk assessments that serve as source documents for regulatory submissions. Author portions of regulatory submissions to designated health… more
- Abbott (Lake Forest, IL)
- …in regulatory preferred but may consider quality assurance , research and development/support, scientific affairs , operations, or related areas. ... IL** currently has an opportunity for the **Director of Regulatory Affairs .** The function of a Director...potential and new acquisitions and advise management. + Set quality and accuracy standards. Anticipate emerging issues and develop… more
- Abbott (Abbott Park, IL)
- …experience in regulatory industry but may consider quality assurance , research and development/support, scientific affairs , operations, or related area + ... colleagues serve people in more than 160 countries. **_Senior Specialist - Regulatory Affairs -Transfusion_** **Working at Abbott** At Abbott, you can do work… more
- Stryker (Cary, IL)
- We are currently seeking a **Principal Regulatory Affairs Specialist,** ( **Pharmaceutical Products** ) to join our **Medical** Division. This is a Hybrid role ... based in Cary, Illinois. **What you will do** As the **Principal Regulatory Affairs Specialist,** you will play a pivotal role in shaping and executing global … more
- Veterans Affairs, Veterans Health Administration (North Chicago, IL)
- …standards, equipment, techniques and methods Responsible for chairing the Biomedical Quality Assurance Committee; Joint Commission preparation; liaison with ... and maintenance of medical equipment. Responsible for chairing the Biomedical Quality Assurance Committee; Joint Commission preparation; liaison with Maintenance… more
- Veterans Affairs, Veterans Health Administration (North Chicago, IL)
- …standards, equipment, techniques and methods Responsible for chairing the Biomedical Quality Assurance Committee; Joint Commission preparation; liaison with ... and maintenance of medical equipment. Responsible for chairing the Biomedical Quality Assurance Committee; Joint Commission preparation; liaison with Maintenance… more
- Abbott (Abbott Park, IL)
- …as well as R&D Quality Assurance , Procurement, Supplier Quality , Regulatory Affairs , site-level Operations, and outside suppliers/vendors. The ... + Responsible for implementing and maintaining the effectiveness of the quality system. **BASIC QUALIFICATIONS | EDUCATION:** + 8-10 years industrial experience… more
- AbbVie (North Chicago, IL)
- …interfacing with many groups external to PDS&T, for example: Manufacturing Operations, Regulatory Affairs , Quality Assurance , etc. Responsibilities: ... strategies, define project responsibilities and timelines o Author and review key regulatory documents, laboratory data, technical memos and reports. . The position… more
- AbbVie (North Chicago, IL)
- …Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs , R&D, and S&T to align strategic initiatives. ... Develop regulatory strategies for brands with Regulatory Affairs . Responsibilities List up to 10...the NPI supply chain & departmental budget. Lead Product Quality Assurance Transfer Mngr.s to develop strong… more
- AbbVie (North Chicago, IL)
- …related issues. + Total combined years of experience. Minimum of 10+ in Quality Assurance Operations Management, Regulatory , Operations, or Technical Support ... performing as leaders, team members and individuals. + Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory , and / or… more
- AbbVie (North Chicago, IL)
- … and Product Development strategies for NPI products in concert with Regulatory Affairs , marketing, Product Development and other cross-functional stakeholders. ... and audits as SME. + Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at… more
- AbbVie (North Chicago, IL)
- …as leaders, members and individuals. + Strong quality assurance /control, manufacturing, laboratory, technical support, regulatory , and/or validation ... and Product Development strategies for NPI products in concert with Regulatory Affairs , marketing, Product Development and other cross-functional stakeholders.… more
- AbbVie (North Chicago, IL)
- …Medical Device External Quality is part of AbbVie's External and Product Quality Assurance group and reports to the Senior Manager, Medical Device External ... out of Lake County, IL site. This role primarily oversees external product quality assurance (EPQA) for commercial medical devices which are manufactured by… more
- AbbVie (North Chicago, IL)
- …and audits as SME. + Participate in the development of global Product Quality Assurance strategy to support device and combination products produced at ... of relevant experience in the medical device industry; at least 5+ years in Quality Assurance experience required. + Working knowledge of ISO 13485, ISO 14971,… more
- AbbVie (North Chicago, IL)
- …event collection and evaluation, signal detection, and signal validation. Familiar with quality assurance , legal and regulatory functions, database ... therapeutic areas. They will design and interpret studies, contribute to regulatory submissions, and provide expertise in regulatory pharmacoepidemiology and… more
- AbbVie (Mettawa, IL)
- …5 years experience with, or exposure to, business functions such as compliance, legal, regulatory affairs , government affairs , and finance. + Builds strong ... Affairs + Health Impact, and other risk and assurance colleagues to fulfill your objectives. Responsibilities: + Be...OEC projects, assessments, and reviews aiming to improve the quality of our guidance, governance or controls. + Plan,… more
- Astellas Pharma (Northbrook, IL)
- …to both the Core Medical Plans and local business needs. . Provide quality assurance controls, and operational assessment/analysis plans relevant to MA ... **Cross Divisional collaboration:** . Collaborate within Development: o Development o Regulatory Affairs o Pharmacovigilance . Collaborate with divisions outside… more
- Abbott (Abbott Park, IL)
- …+ Minimum 3 years auditing experience + Minimum 3 years' experience in Quality Assurance or another function in the pharmaceutical, medical device, nutritional ... our Abbott Park, IL location for our AQR Abbott Quality and Regulatory division. The Compliance Auditor...Science. + One or two years in Compliance or Regulatory Affairs is desirable. Learn more about… more
- Abbott (Abbott Park, IL)
- …+ Effective time management skills **Preferred Qualifications** + 8+ years in Quality Assurance or Engineering function in pharmaceutical, device or nutitional ... of our corporate Abbott Park, Illinois location. The Abbott Quality and Regulatory (AQR) Global compliance audit...desirable + One or two years in Compliance or Regulatory Affairs is desirable * Participants who… more