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Frorn: <br />07/20/2015 07:18 •i 008 P.000/010 <br />,IULI C. RUBIN <br />480 Costa Lane little Canada, MN 55117 612-669.4998 juli,tidwell@gmail.com <br />EDUCATION: <br />UNIVERSITY OF MINNESOTA, Minneapolis, Minnesota <br />Carlson School of Management <br />Master of Business Administration <br />Emphases: Consulting and Medical Industry Leadership Institute <br />December 2009 <br />GPA: 3,556 <br />Bachelor of Arts in Theatre Arts and Dance; Studies in Cinema and Media Culture May 2004 <br />EXPERIENCE: <br />NORTH ANOKA CONTROL SYSTEMS (NACS),1-lam Lake, Minnesota November 2014 -Present <br />Quality Manager <br />• Established, implemented, and managed the overall quality system in compliance with 1S0 9001, ISO <br />13485, 21CFR820, 21012210/211, and 21CFR11. <br />• Developed and implemented quality documentation; including: Quality Policies, Standard Operating <br />Procedures, Job Instructions, Manufacturing Procedures, Material and Design Specifications, and <br />Training <br />• Developed and implemented quality improvement initiatives based an Six Sigma/Lean methodologies <br />• Directed internal and external (customer, supplier, and regulator) audit, CAPA/NC, employee training, <br />and EHS programs <br />• Conducted and managed risk management activities on production processes and equipment <br />• Directed all verification and validation activities, including 1Q/SWQ/0Q/PQ/PPQ/DOE/Calibrations <br />• Managed technical staff in carrying out quality control/assurance activities <br />• Authored technical and management system reports and reported to executive management on quality <br />system health, issues, and trends <br />• Managed quality inspection and product release program for finished goods, as wells as incoming and <br />in -process materials and components <br />• Served as liason to customers for all quality and compliance matters <br />• Managed all regulatory and compliance activity (registrations, licensing, inspections, etc.) <br />• Responsible for overall compliance with national and international standards and regulations <br />• Successfully completed ISO 9001/13485 Lead Auditor Certification Training <br />• Successfully completed Manufacturer's Alliance Six Sigma Green Belt Training <br />BOSTON SCIENTIFIC, St, Paul, Minnesota October 2009 -October 2014 <br />Senior Regulatory Affairs Specialist <br />• Authored pre -and post -market submissions to obtain and maintain approvals for commercially <br />distributing products worldwide. included sPMA, Design Dossier, CE Certificate Renewals, IDE, 30 - <br />Day Notices, etc. <br />• Developed and implemented regulatory strategies for new and existing Class 11,111 and AIMD medical <br />devices <br />• Reviewed and approved pre- and post -market V&V protocols and test reports to ensure compliance <br />with global regulatory and standards requirements <br />• Managed overall CE Certificate Renewal program <br />• Led cross -functional and cross -divisional Six-Sigma/LBP and quality assurance projects <br />• Developed and maintained positive relationships with regulatory agencies through oral and written <br />communications regarding pre -submission strategy/regulatory pathway development, testing and <br />clinical requirements, clarification and follow up of submissions under review <br />• Reviewed device labeling and advertising materials for compliance with submissions and applicable <br />regulations; analyzed and recommended appropriate changes <br />• Participated in internal and external (FDA, Notified Bodies, TOA, Health Canada) audits <br />