Quality Systems Engineer
Lead the development and maintenance of a robust quality system in compliance with all relevant standards and regulations. Create and deploy quality system processes in support of corporate objectives. Serve as subject matter on and lead internal audit program. Directly involved in shaping strategies that will support on-going improvement and effectiveness of the quality system.
Initiate, facilitate and/or manage projects to expand, change, enhance and improve the quality system, as assigned through the QMS integration project
Bachelor degree or Master degree in Engineering.
7 years Quality Systems experience
Demonstrated expertise and hands-on experience with FDA regulations, FDA QSR, ISO 13485:2016, Medical Device Regulation, and other national and international regulations (MDSAP, etc.).
Ability to respond to inquiries from customers, regulatory agencies, or members of the business community.
Strong written and verbal communication skills and interpersonal skills to effectively translate ideas, concepts and information clearly and concisely.
Demonstrated project management skills in order to plan, conduct and implement system assessments.
Experience with QMS integration project and working cross-functionally to drive project completion