Manufacturing Quality Engineer

Department: Operations

Reports to: Engineering Manager

Location: Corporate Office (Cleveland, OH)

Principal Duties and Responsibilities: The primary responsibility for this team member will be Operations and Product Development support for nerve protection and repair surgical devices. This will include:· Support outsourced, mainly domestic, production of new medical devices by identifying and coordinating with contract manufacturers to ensure quality and delivery goals are met.· Production support for current products including supplier selection, management, and CAPA execution· Quality and manufacturing support for product development projects according to Design Control procedures.· Assist in design for reliability, regulatory compliance, manufacturability, inspectability and cost control for current and new products· Conduct root cause analysis and customer feedback investigation to support production issue resolution· Create, oversee and/or execute production process qualification and validation activities· Supports the evaluation and potential addition of internal manufacturing capabilities, including the potential insourcing of currently outsourced processes.· Create and execute protocols for testing/analyzing products to demonstrate function and required regulatory compliance.· Creation and management of relevant design control documentation for products. Expected Areas of Competence· Full working knowledge of and significant level of experience with outsourced product development and production. Preference for Medical device experience.· Demonstrated ability to methodically investigate, determine solutions and resolve complex problems.· Ability to develop or identify new technologies to address problems.· Ability to develop and maintain project schedules to meet team goals· Professional, concise, tactful and sensitive in communications.· Collaborative when communicating with internal personnel, and external customers and vendors.· Demonstrated good written and verbal communication skills· Leadership in the creation and improvement of internal processes.· Microsoft Office Suite. Education and Professional Requirements:· Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, Materials science, or related field.· 5-7 years experience with Manufacturing or Quality Engineering· Prefer 3 years of experience with FDA regulated medical devices· Experience working within a regulated environment such as ISO 13485 or ISO 9001 standards· Track record of project leadership and commercialization, including manufacturing support, of medical devices· Project management including planning, execution, budgetary constraints.· Understanding of medical device DHF, DMR, and DHR files management and documentation requirements.· Desire to work in a fast paced, small company environment as an integral part of a team