Quality Engineer

Summary:As a Quality Engineer for the organization you will be an integral part of the maintenance and improvement of the company’s quality management systems adherence to ISO and Regulatory requirements.In the role of Quality Engineer:You will lead CAPA activities and non-conformance investigationsYou will develop and lead implementation of continuous improvement plansYou will lead supply chain quality management activities including audits and vendor CAPA’sYou will manage the incoming inspection departmentYou will participate in activities to ensure manufacturing processes are properly validated and in compliance with company, ISO, and regulatory requirementsYou will participate in the development of Failure Mode and Effects Analysis (FMEA)You will lead internal quality system auditsYou will lead audits from regulatory and safety agencies, customers, and registrars You will participate in design reviews as neededThe skills you need to succeed:You must have strong goal attainment orientation with team focusYou must have the ability to work in environments experiencing routine and rapid changeYou must have excellent organization and decision making skillsYou must have strong mentoring and leadership skillsYou must be a self-starter, possessing high degree of self-motivationEducation and experience of a successful candidate:Bachelor’s degree in a related engineering discipline4+ years related experience in the development and maintenance of quality management system and documentation control processes and proceduresRelated experience in an FDA regulated medical device company is strongly desiredStrong working knowledge of FDA medical device regulations, and ISO 13485 requirements in quality management systems and documentation controlExperience with printed circuit board assembly and test highly desirableExperience implementing lean manufacturing and/or six sigma desirableAdvanced word processing (Microsoft Word), database (Access) and spreadsheet (Excel) skills