- Zimmer Biomet (Warsaw, IN)
- …procedures, specifications, and standards for Zimmer products and processes; lead quality engineering projects from concept through design, implementation, testing, ... Office Suite, Blueprint reading and geometric dimensioning and tolerancing; and QSR /ISO regulations, design assurance, FMEA, and product testing methods. Must have… more
- Cordis (Miami Lakes, FL)
- …and multi-lumen tubing, thin-wall profiles, co-extrusions, and balloon films. + Lead process validation (IQ/OQ/PQ) activities, ensuring compliance with ISO 13485 and ... FDA QSR requirements. + Troubleshoot and resolve extrusion process issues,...compliance to ISO 13485 and FDA 21 CFR Part 11/ QSR . + Proficiency with statistical analysis tools and process… more
- GE HealthCare (Arlington Heights, IL)
- …applicable Environmental Health & Safety (EHS) and Quality System Requirements ( QSR 's). **Qualifications/Requirements** + Associate degree plus a minimum of 1 year ... live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding… more
- Jackson Spalding (Atlanta, GA)
- …is seeking an enthusiastic digital intern to work with a nationally recognized QSR client on social media community management. You will move quickly through the ... and skill set. Internships are paid, typically three to six months in length, and may lead to full-time employment. We work a hybrid schedule - 3 days in office and… more
- Abbott (Pomona, CA)
- …female executives, and scientists. **The Opportunity** The **Project Manager** will lead cross-functional teams in the development and commercialization of In Vitro ... projects or priorities concurrently. + Knowledgeable of federal and other regulations, eg QSR 's, ISO, ISO 13485, CMDR. + Understands and is aware of the quality… more
- J&J Family of Companies (Santa Clara, CA)
- …medical device industry is strongly preferred + Strong understanding of cGMP, FDA 820 QSR , ISO 13485, or other Quality Systems + Strong technical writing skills + ... testing, capability analysis, DOE, MSA, Gage R&R), Six Sigma, Lean + Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus + Able to lift… more
- Battelle Memorial Institute (Columbus, OH)
- …with the program manager as both an individual contributor and or a technical lead responsible for guiding other engineers also depending on the needs of the ... plastic part experience + Understanding of the FDA Quality System Regulation ( QSR ) and involvement in an ISO13485 operational environment **Travel Requirements:** up… more
- AbbVie (Irvine, CA)
- …the following (other duties may be assigned.): + Act as a technical lead for product development projects. Provide mentoring and guidance to other team members. ... for performing all duties in compliance with FDA's Quality System Regulation ( QSR ), ISO13485, the Canadian Medical Device Regulations, and all other international… more