About this role
Manager, Medical Device Quality Engineering
Job Description: Lead multiple quality-related initiatives. Manage Design Quality Engineers and Technicians who support the development and manufacture of medical devices. Directly support and lead assigned R&D product development projects, design changes and design improvements, and KTBR (Keep the Business Running) initiatives as the Design Quality Engineer representative in the Core Team, while simultaneously managing the Design Quality Engineering team. Work with R&D, Manufacturing, and Production Quality Engineers to ensure the Design Quality engineering support for the resolution of product quality issues and provide technical expertise. Ensure regulatory compliance with applicable FDA, ISO 13485, and worldwide regulatory requirements. Job duties: • Lead and develop direct reports with varying technical experience from entry to senior level roles including task assignment, review, coaching, and mentoring. • Assist product development teams in following the design control process. Ensure that teams follow design control processes defined in applicable FDA regulations, international requirements, and Company procedures. • Provide leadership in technical aspects of quality assurance including risk analysis, design verification, design validation, process validation, test method validation, and data analysis. • Manage Quality Engineers supporting R&D product development. Independently lead assigned development projects while providing direct design quality support throughout the design control process. Mentor and coach engineers on design control activities. • Ensure adequacy of Quality Engineers by assessing performance, providing individualized training, providing appropriate assignments, and evaluating potential candidates. • Instruct Design Quality Engineers to appropriately use statistical methods such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, design of experiments, gauge repeatability and reproducibility, etc. to inform decision making and conclusions. • Serve as the Design Quality Lead for assigned New Product Development (NPD), Product Lifecycle Management (PLM), sustaining engineering, cost improvement, supplier change, and KTBR projects from concept through commercial release. • Independently perform Design Quality Engineering activities, including development and review of Design and Development File (DDF) documentation, risk management, design verification and validation, process validation, test method validation, statistical analysis, engineering change assessments, and resolution of technical quality issues. • Provide hands-on technical leadership to R&D teams by participating in design reviews, evaluating technical decisions, identifying quality and regulatory risks and proposing solutions, and ensuring compliance with FDA regulations, ISO 13485, IEC 62366-1, ISO 14971, and applicable country-specific standards and company procedures. • Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. • Perform additional duties as assigned.
Qualifications: • Bachelor’s degree in science or engineering. • Minimum six (6) years of engineering experience in the medical device industry. • Minimum one (1) year of management or supervisory experience/responsibility. • Strong abilities at reading, preparing, and reviewing technical documentation. • Strong written and verbal communication skills. • Strong interpersonal and management skills. • Proficient computer skills including MS Word, Excel, Outlook, Teams, and Minitab. Desired Qualifications • Solid knowledge of US and foreign regulations relative to the design, manufacturing, distribution of medical devices, quality systems and other standards for the medical device industry. • Good working knowledge of statistical analysis techniques. • Demonstrated experience leading Class II and/or Class III medical device development project. • Strong understanding of FDA Design Controls (21 CFR 820), ISO 13485, ISO 14971, IEC 62366, and applicable international regulations. EEO We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.
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