- Abbott (St. Paul, MN)
- …related to biocompatibility, in compliance with applicable global regulatory requirements (eg FDA , ISO, MHLW, and CFDA). * Assist the biocompatibility team members ... Biotechnology fields with expertise in biocompatibility, toxicology, and/or special process validation . A master's degree in a relevant engineering or scientific… more
- Abbott (Plymouth, MN)
- …prepares reports and recommends improvements. + Conduct inspection, verification and validation of components or materials used in development processes. + Identify ... report needs to be filed with various global regulatory agencies (eg, FDA , European Competent Authorities) and sends reports within required timeframes + Supports… more
- Danaher Corporation (Chaska, MN)
- …oral and written reports; update documentation promptly. + Ensure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO ... also possess previous experience in: + Project Management experience + Validation /verification experience and Process transfer + Experience in a regulated industry… more
- Abbott (Plymouth, MN)
- …but not limited to: Production and Process Control subsystem SME, Validation Process Owner, Process Monitoring Process Owner, etc. Directs multi-site, Division-wide ... + Frequently represents Division during internal and external inspections such as FDA , ISO, and AQR. + Interprets regulations and requirements and implements… more
- Abbott (St. Paul, MN)
- …from within the clinical function for product development work, Design Validation and Verification activities, and will support pre-clinical activities. This role ... function for product development as well as Design Verification and Validation activities. + Develops, leads and/or facilitates technical device-based training… more
- ManpowerGroup (Eagan, MN)
- …improvement of existing products. This includes design, documentation and validation testing.** **ESSENTIAL JOB DUTIES & RESPONSIBILITIES** **Design and ... manner that supports agency listings and certifications** + **ISO 13485** + ** FDA registration** **Follow product development process as defined in the Quality… more
- Medtronic (Mounds View, MN)
- …design of experiments (DOE) constructs. Support product design verification and validation . Coordinate Reliability Engineering for Class II and III Medical Devices. ... Navigate the complexities of industry and government regulations to include FDA Quality System Regulation (QSR) 21 CFR 820, ISO 13485, EU Medical Device Regulation… more
- Abbott (St. Paul, MN)
- …including but not limited to requirement development, testing and data analysis, validation testing, and serving as a clinical consultant on clinical workflows and ... supervisor. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
- Fujifilm (St. Paul, MN)
- …to oversee all technical aspects of Synapse product implementation, fromsolution validation phases through product go-live. The Project Engineer (PE) must have ... NFS, CIFS, DAS. + Disaster Recovery (DR) setup and validation : Backupexec, NAS or Tape media. + Plan and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Philips (Plymouth, MN)
- …issues. + Developing and overseeing equipment qualification and process validation plans and lead continuous improvement projects based on process/product ... change requests from suppliers, ensuring appropriate regulatory review and adequate validation to support requested changes. + Serving as internal and supplier… more