- Insight Global (Nogales, AZ)
- …or related technical discipline. - Minimum 5 years of experience in a quality engineering role within a FDA -regulated medical device or pharmaceutical ... System (QMS) for assigned business units complies with applicable FDA regulations (21 CFR Part 820), ISO 13485, and...root cause analysis and process improvement. - Proficient in quality systems software (eg, LIMS, SAP, TrackWise,… more
- Fujifilm (Bothell, WA)
- …Our headquarters in Bothell, Washington, blends riverside charm with urban amenities, quality schools, and an ever-evolving downtown-all part of the vibrant Seattle ... with cross-functional project team and in compliance with QSR820.1 ( FDA medical device) requirements. + Build and lead a...project goals on time with a high level of quality , while managing expectations of stakeholders + Work collaboratively… more
- AbbVie (Pleasanton, CA)
- …Additional Requirements: * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device ... with preferably no managerial intervention. Qualifications * BS in Mechanical, Software , Electrical Engineering or equivalent degree. Advanced degree desirable. *… more
- AbbVie (Irvine, CA)
- …Additional Requirements: * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device ... with preferably no managerial intervention. Qualifications * BS in Mechanical, Software , Electrical Engineering or equivalent degree. Advanced degree desirable. *… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …capture improvement opportunities including non-product softwareEssential Functions + Performs internal quality audits and effectiveness reviews ( FDA 's QSR, ISO ... + Prepare, submit and coordinate the process validation requirements for non-product software validations + Participates in the FDA premarket approval process… more
- Abbott (Lake Forest, IL)
- …Our 114,000 colleagues serve people in more than 160 countries. **Senior Manager, Software Quality and Cybersecurity - Informatics** **Working at Abbott** At ... female executives, and scientists. **The Opportunity** The **Senior Manager, Software Quality and Cybersecurity - Informatics** role...+ Ensure compliance with global regulations and standards (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971,… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …for investigation and Regulatory Affairs for arranging more information/ samples from FDA . + Managing Quality Management Review meetings, circulating minutes of ... Quality Compliance Manager Department: Quality Location:...Product Recalls, making sure no delay in submission to FDA per defined timeline. After initial submission, keeping track… more
- DuPont (Hemlock, MI)
- …(US 21 CFR 820) and FDA regulations. + Lead the overall Liveo (TM) Quality unit, especially with people leadership and mentoring of the Quality Team. + Work ... standards and are monitored appropriately through audit programs. + Oversee the Computerized Quality System Software Validation to ensure new systems and system… more
- Abbott (Santa Clara, CA)
- …, cybersecurity, telehealth, etc.) have targeted mitigations to align with FDA expectations, ensuring high- quality submissions and predictability for approval ... experience with US submissions and a solid knowledge of FDA regulations + Strong understanding of software ...of FDA regulations + Strong understanding of software lifecycle management, including design, validation, and maintenance in… more
- Curia (Rensselaer, NY)
- Supervisor, Quality Control - Onsite position in Rensselaer, NY - 12 Hour Nights The Quality Control Supervisor is responsible for overseeing routine and ... functions of their department, and manage a team of Quality Control Chemists. This position may require work outside...team resources + Expert in cGMP, USP, EP and FDA regulations Knowledge, skills and abilities + Ability to… more