Job Summary: The Quality Engineer is responsible for providing technical leadership for all aspects of quality engineering and product safety throughout the product realization process. This position will handle multiple projects from product inception, development, through manufacture and customer use. The incumbent provides a key role to ensure product meets defined quality and safety standards, and worldwide regulatory requirements. The incumbent will also support all facility activities, including design control activities, process validations and inspection and test activities. Duties & Responsibilities: Assist Quality Manager on the quality assurance and product quality Supports new product development and product manufacturing through the application of quality engineering tools Assure conformance of systems and processes during the development, manufacture, and quality control operations with respect to internal procedures, Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR) MDD 93/42 EEC and other applicable international standards and regulations Leads and participates in problem solving activities related to design, manufacture and inspection and test, including CAPA, NCR and supplier related issues Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution Leads and participates in IQ/OQ and PQ activities, test sample size selection, test method validations, Gage R&R studies and risk management activities to assure conformance to product quality standards and applicable regulations Develops and manages programs that monitor, predict, or regulate research and development, manufacturing, and inspection activities. This may be accomplished through the application of statistical tools such as Minitab and/or SQC pack In conjunction with the QA management, ensures robust application of the quality system by supporting the management review process, including the generation of data for CAPA, NCR, in RI and in process inspections, internal and external, audits and customer feedback activities Participates with regulatory compliance group in leading and developing Risk Analysis according to ISO 14971/ IEC 60601-1, 3rd Edition Interfaces with various product certification agencies such as UL, CSA, and external laboratories to obtain product safety certifications to applicable product safety standards (i.e., IEC 60601-1, 3rd Edition, ISO 80601-2-61, etc.) Works to be an in-house expert in product safety standards Provides design reviews to applicable product safety standards. Responsible for creating in-house product safety reports aligned to IEC formats for pre-compliance design reviews. Develop and maintain Design History Folders (DHF) for products. Any reasonable task assigned by Superior from time to time Minimum & Preferred Qualifications and Experience: Minimum Qualifications: Five to seven years of experience in product safety/ project management including practical experience in a device manufacturing environment Direct experience with IEC 60601-1, 3rd Edition and ISO 14971 or ISO 13485 Root Cause Investigation, failure analysis, root cause verification and developing robust corrective and preventive actions Test protocol development and testing as part of root cause and failure verification Direct experience in quality system audits Ability to occasionally travel internationally Proficiency with Microsoft Office applications Strong communication, documentation, problem solving and leadership/management skills Strong Project Management experience Must be an independent worker, who is flexible and adaptable Preferred Qualifications: Microsoft office knowledge Experience in Risk Management to ISO 14971 and IEC 60601-1, 3rd Edition Experience generating IEC formatted test reports Experience in evaluating products to Product quality Standards Technical knowledge experience in electronic manufacturing Education: B.S. in Science or Engineering is required. M.S. in Science or Engineering, or an MBA, is preferred. Physical requirements/Work Environment This position works in office, laboratory and manufacturing environments. It requires frequent sitting, standing and walking. He or she needs to be able to recognize and differentiate color. He or she must also be able to lift up to 50 pounds. Daily use of computer and other computing and digital devices is required. He or she may stand for extended periods when facilitating meetings, walking in the facilities, performing audits and laboratory testing. Some international travel is required, so a valid international travel passport is required. Also, some local is necessary, so the ability to operate a motor vehicle and maintain a valid driver license is required. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with reals or perceived disabilities to perform the essential functions of the job described
