Experience

COLTENE SciCan

• Canada
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Quality Assurance Manager

  • Jan 2016 - Present

   Lead the maintenance of the company’s accreditation for ISO13485 and MDSAP as well as Council Directive 93/42/EEC and CFR 820. Responsibilities include, overseeing the CAPA process, vendor management, Internal and external audits and risk management.  Responsible for company Drug program in compliance with GMP regulations  Lead Vendor audits for ISO 9001 compliance assessment.  Leads the Quality team (Four quality engineers two inspectors, a drug specialist and Complaint officers).  Led the implementation of Quality Management system Software (including in house Validation program).  Trained managers and implemented Risk Management plan (Per ISO 14971). Show less



Kangaroo Group

• Toronto, Canada Area

• Manufacturing Quality Manager

  • Oct 2013 - Jan 2016

  Maintain Kangaroo accreditation (ISO13485 Medical devices Quality management systems Requirements for regulatory purposes). Develop a cost effectiveness inspection system including staff training including test equipment identification. Lead quality department of 4 employees. Cover quality aspects of client's communication including quality reports, Failures and Corrective actions correspondence. Lead FMEA and risk management processes. Deliver and maintain Kaizen workshop. Responsible for company regulatory records maintenance. Show less



Quality Services North America

• Toronto Ontario

• Owner

  • Apr 2011 - Oct 2013

  Quality services North America, enable you to save on quality audits: Whether it's first or second party audit, we are here to serve, Just continue your daily tasks and our proffesional staff, will audit and provide you a detailed audit report. We are experts of the following standarts; ISO 9000, AS 9100, ISO/TS 16949, ISO 14000 and OHSAS 18,000. Quality services North America, enable you to save on quality audits: Whether it's first or second party audit, we are here to serve, Just continue your daily tasks and our proffesional staff, will audit and provide you a detailed audit report. We are experts of the following standarts; ISO 9000, AS 9100, ISO/TS 16949, ISO 14000 and OHSAS 18,000.



Ricor

• Defense and Space Manufacturing
• 1 - 100 Employee

• Quality Director

  • May 1994 - Sep 2010

   Reduced the percentage of product failures both, in field and on 'inspection' stage.  Achieved and maintained Ricor accreditations (ISO 9,001 Quality management system, OSHAS 18,001 Safety standard & ISO 14,001 Environmental Management System).  Developed new techniques for suppliers' performance analysis and ranking.  Spotted the reasons for repeated rejections, during Supplier Audits, and solved issues  Decreased inspection costs by 30% by changing process flow and analyzing the cost effectiveness of each test.  Actively supported product development process, including Engineering FMEA, reliability prediction and qualification plan preparation.  Identified and implemented corrective activities in accordance with interior failures and customer returns.  Covered quality aspects of customers' communications (failures and configuration management claims)  Inverted the company’s engineering archive to a company wide database.  Led implementation of SPC in the mechanical workshop.  Implemented new inspection methods and test equipment.  Developed educational workshops and organized social activities for employees Show less