- Family Dollar (Chesapeake, VA)
- …industries. (pharmaceutical or medical device industry preferred). + Working knowledge of FDA Quality Systems (cGMP) and regulatory requirements (eg, 21 CFR ... of the Quality Assurance Manager for product quality , safety, efficacy, development, and compliance to cGMP requirements. You will be trained and qualified… more
- Danaher Corporation (Bothell, WA)
- …and oligonucleotide reagent products, supporting facilities and equipment qualification, and strengthening compliance to FDA 's Quality System Regulation and ... process transfer, validation, data analysis, monitoring, and continuous improvement. + Support Quality System processes to ensure compliance to the Cepheid … more
- ARTIDIS (Houston, TX)
- …of received goods + Execute all local Quality Management activities in compliance with FDA Requirements + Ensure compliance assurance and monitoring ... or diagnostics environment + Sound knowledge of ISO 13485:2016 and an understanding of FDA Quality System Regulation (21 CFR Part 820) + Hands-on experience in… more
- Medtronic (North Haven, CT)
- …as a **subject matter expert** (SME) for one or more Quality System elements in compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other global ... pain, restore health, and extend life. As a **Senior Quality Systems Specialist** , you will play a critical..., you will play a critical role in ensuring compliance with global regulatory requirements while helping to continuously… more
- GE HealthCare (Waukesha, WI)
- …developing, and implementing automation solutions that enhance manufacturing efficiency, ensure product quality , and maintain compliance with FDA and ISO ... production. + Lead the development and validation of automated equipment in compliance with internal quality systems + Collaborate with Design Engineering,… more
- Danaher Corporation (Richmond, IL)
- …medical device/IVD + Experience working within a medical device quality system in compliance with US FDA , ISO 13485 and EU MDR/IVDR regulations + Proven ... workflows, CDT&R, and calibration. This position reports to the Director, Quality Assurance and Regulatory Compliance responsible for ensuring that… more
- Actalent (St. Louis, MO)
- …+ Develop, implement, and maintain Quality Management Systems (QMS) in compliance with FDA , EMA, ICH guidelines, and other regulatory requirements. + ... compliance with all relevant regulations and standards, leading quality initiatives, and supporting the manufacturing of pharmaceutical products. Responsibilities… more
- Stryker (Portage, MI)
- …engineering, human factors engineering, risk management, and design validation, all while ensuring compliance with FDA Quality System Regulations and ISO ... Styker is hiring a **Senior Engineer, Advanced Quality ** to support Instruments-Neurosurgical (https://www.stryker.com/us/en/nse.html) ! In this role, you will lead … more
- Kelly Services (Bloomingdale, IL)
- …protocols. + Ensure adherence to Del Medical's Quality Management System (QMS), including compliance with FDA 21 CFR Part 820 and ISO 13485. + Participate in ... key role in upholding Del Medical's commitment to product quality , reliability, and safety in accordance with FDA...**Corrective Action Closure Time** : Average time to resolve quality issues requiring CAPA (where involved). ** Compliance … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …assessments as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas ... Functions as team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance . Performs routine assignments independently; supports and… more