ASQ certified quality systems specialist, supplier quality and regulatory compliance specialist with over 40 years of proven success in achieving ambitious process performance and organizational objectives; successfully implemented ISO 9001, 13485, 14001 & 14971 QMS & Risk management standards at 20 locations; proven leadership in all aspects of Excellence and Change management; Root cause analysis through Appreciative Audits, and Creative problem resolution for design innovation, and systematic analytical methodology has consistently increased system and process efficiencies and product reliabilities at 10 manufacturing, chemical and research facilities.
Experience: 40+ years
Email: tmalik@complianceontap.com
Tel: +(1)604-710-8182
Expertise spanning over 30 years in cross-functional roles within the MedTech and electronic product sectors includes comprehensive knowledge of the life-cycle of technology ventures as well as proven, hands-on achievements in product development, regulatory submission and technical file preparation, project management, business development, and team leadership. Core skillset consists of electrical engineering technology, product certification, compliance engineering, QA/RA direction and product design. Ability to deliver solutions to clients and other stakeholders on short timelines and within budget.
Experience: 30+ years
Email: csomow@complianceontap.com
Tel: +(1)604-220-0799