- Community Health Systems (Fort Wayne, IN)
- …Biomedical Services fiduciary results for the assigned facilities. Responsible for all medical device required regulatory compliance for the assigned facilities. ... sustains relationships with facility staff and vendors. + Manages Medical Device Life-Cycle. + Works with the...to optimize quality and overall efficiencies. + ** Quality Assurance and Regulatory Compliance** + Ensures… more
- Terumo Medical Corporation (Baltimore, MD)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications ... of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in...complaints (ie adverse events, product performance reports, etc.) to Quality Assurance (QA), and by ensuring all… more
- Access Dubuque (Dubuque, IA)
- …Science, Biology, Chemistry, or related field with 1-3 years of regulatory affairs, quality , or medical device experience. Lead Auditor experience preferred. ... team. This person will work directly with Engineering and Quality Assurance to maintain the knowledge base...compliance to ISO 13485, FDA 21 CFR 820, and Medical Device Single Audit Program. Lead the… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- … device /IVD industry employment position such as post-market surveillance, quality assurance , regulatory affairs, clinical affairs or product development + ... device /IVD industry employment position such as post-market surveillance, quality assurance , regulatory affairs, clinical affairs or product development +… more
- Medtronic (Denver, CO)
- …expense reports + Report device complaints to proper departments within quality assurance within Medtronic + Schedules travel arrangements to ensure multiple ... surgery, Surgical Aortic Valve Replacement (SAVR) experience preferred. + Strong, proven medical device sales track record with documented growth and… more
- AbbVie (North Chicago, IL)
- …optimization. + Leads the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...to timelines, resources and conflicting priorities. + Interfaces with Quality Assurance audit team to develop audit… more
- AbbVie (Waco, TX)
- …+ Ability to communicate and collaborate with other departments such as the Device Analysis Lab, Quality Assurance , Regulatory Affairs, Clinical Studies, ... 21 CFR 803, 21 CFR 4, CMDR SOR/98-282, ISO 13485:2016, European Union Medical Device Regulation and applicable international vigilance regulations. + Conduct,… more
- US Tech Solutions (Thousand Oaks, CA)
- …combination of education and/or experience. + Typically, 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or ... medical device industry. + Evaluate documentation and operation according to company guidelines. + Be self-motivated, attentive to details and able to prioritize… more
- Cook Medical (Bloomington, IN)
- Overview The Packaging Engineer 2 uses their experienced in medical device packaging to design and develop solutions for new and modified products. This includes ... a cross-functional team including SBU Product Management, Regulatory Affairs, Operations, Quality Assurance , Clinical Affairs, and other Engineering personnel.… more
- Olympus Corporation of the Americas (Westborough, MA)
- …requirements for digital health products and solutions, ensuring compliance with global medical device regulations. As part of a high-growth, innovative team, ... digital health solutions, including Artificial Intelligence (AI) exempt from the medical device classification, and connected technologies. + Provide regulatory… more