Quality Engineer II (Electronics)

Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment.

Summary of the role

As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.

Summary

Responsible for supporting and improving the Quality Management System (QMS) related to the design, manufacture, and post-market quality of medical devices. The . The QE II provides guidance to QE I-level engineers and Technicians, supports validation activities, and serves as a cross-functional liaison with Manufacturing, R&D, Regulatory, Engineering, and Supply Chain teams. This role requires strong analytical skills and the ability to interpret data to drive quality and business decisions, along with the capability to manage multiple priorities in a regulated, high-paced environment.

General Duties and Responsibilities

• Lead complaint and nonconformance investigations, conduct root cause analysis, and implement corrective and preventive actions.
• Support new product development projects by leading quality-related deliverables including risk management, verification / validation plans, and design reviews.
• Develop and maintain risk management documentation (e.g., DFMEA, PFMEA) per ISO 14971.
• Author and execute validation protocols including IQ, OQ, PQ, test method validations, and software validation.
• Review and approve engineering change orders (ECOs), validation documentation, and technical justifications.
• Provide daily quality engineering support to manufacturing for embedded software systems, PCBAs, and electro-mechanical assemblies.
• Analyze product and process data to monitor trends, reduce scrap, and improve product performance and process capability.
• Support supplier quality activities including evaluation of supplier change notifications and supplier corrective actions.
• Participate in internal audits and regulatory inspections (FDA, ISO, MDSAP), including document prep and audit support.
• Assist in the development and improvement of inspection methods, control plans, and work instructions.
• Drive and support continuous improvement by identifying and helping implement process enhancements.
• Mentor junior quality personnel and serve as a resource for technical guidance.
• Perform other quality duties as assigned.

Qualifications :

Interested?

If you are interested in being a part of a team and creating an inclusive and diverse workplace, please apply online with your CV.

About Nordson Medical

At Nordson MEDICAL, you don't have to be a doctor to help save lives. We are the global expert in the design, development, and manufacturing of complex medical devices and component technologies. By joining our team today, you will help us bring innovative ideas to life. Nordson MEDICAL is a global team that works to create components for life-saving medical devices. We offer a supportive culture in a growing and dynamic work environment. Whether you're just beginning your career or you're a seasoned professional, there's a place for you to belong at Nordson MEDICAL. We offer hourly and salary positions in production, maintenance, customer service, quality, engineering, and more. We actively invest in our teams to help you build your skillsets and advance your career.