Senior Design Quality Engineer

Senior Design Quality Engineer Advanced Instruments, LLC (Now Nova Biomedical) Join us at Advanced Instruments, a newly united brand under Nova Biomedical, delivering world?class medical and life?science instrumentation for over 70 years of scientific excellence. We are headquartered in Norwood, MA, with a global team of nearly 2,000 employees and a culture built on Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity. About The Role This Senior Design Quality Engineer plays a pivotal role in the development and implementation of design processes and quality assurance systems for our medical and life science instrumentation. The Principal DQE ensures that our products meet both external regulatory requirements and internal company standards. Key Responsibilities Develop and implement quality plans, verification and validation plans, and other quality documents for medical electrical equipment design projects. Perform design reviews and risk assessments to identify potential quality and compliance issues. Collaborate with cross?functional teams to establish and maintain design traceability from requirements gathering through to design outputs and post?market activities in compliance with regulatory standards (such as FDA, ISO 13485). Lead verification and validation activities for medical devices, including protocol development, testing, and analysis of results driven by new product development and/or product sustainability. Manage corrective and preventive actions (CAPA) related to quality issues, including training and leading quality investigations and routine meetings. Facilitate the transition of new products from development to production, ensuring adherence to quality standards. Stay up?to?date with regulatory changes and industry best practices regarding medical device quality assurance. Requirements Minimum of 8 years of experience in quality engineering and/or compliance within the medical device industry, preferably with medical / IVD electrical equipment. Profound understanding of medical device and IVD regulations (FDA 21 CFR Part 820, ISO 13485, ISO 14971, IVDD, IVDR). Demonstrated expertise in design controls, with a strong focus on design traceability, inputs, outputs, verification, and validation processes. Excellent analytical and problem?solving skills, with the ability to lead root cause analysis and implement effective solutions. Must understand statistical analysis, statistical process control, investigation, and corrective and preventive action processes. Strong interpersonal and communication skills, with the ability to work effectively in a team environment and interact with all levels of management. Proficiency in statistical analysis software and quality management systems preferred. Auditing experience and/or audit certification is a plus. Location In?office, Monday?Friday, Norwood, MA. Whats In It For You? Flexible Medical, Dental, & Vision Coverage Competitive 401(k) Company Match Bonus Program, Generous PTO and Paid Holidays Generous Tuition Reimbursement Professional Development, Engagement, and Events Company Marketplace for Lunch and Snacks EEO Statement Advanced Instruments takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As part of our commitment, we assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. #J-18808-Ljbffr