Quality Engineer II (Electronics)

Quality Engineer II (Electronics) Nordson - 3.2 Allen, TX Job Details Full-time 8 hours ago Qualifications Supplier quality engineering experience within electronics industry Statistical analysis tools Full Job Description 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. Quality Engineer II - Electronics Allen, TX | Full-Time About the Role We are seeking a Quality Engineer II - Electronics to support and enhance our Quality Management System (QMS) while ensuring the quality and compliance of electronic components and medical devices across their lifecycle—from design and manufacturing to post-market performance. In this role, you will lead quality initiatives, drive problem-solving activities, and collaborate cross-functionally to ensure products meet regulatory and customer requirements. This is a high-impact position requiring strong analytical skills, engineering judgment, and the ability to manage multiple priorities in a fast-paced, regulated environment. What You'll Do Lead investigations for complaints, nonconformances, and CAPAs, including root cause analysis and effectiveness checks Drive CAPA activities to timely and effective closure Partner with Manufacturing, R D, Engineering, Regulatory, and Supply Chain teams to support product quality Support and execute validation activities (IQ/OQ/PQ), test methods, and equipment qualifications Develop and maintain risk management documentation (FMEAs, risk assessments) Analyze data trends to identify improvement opportunities and reduce variability Support supplier quality initiatives, including monitoring, audits, and corrective actions Review and approve engineering changes, validation documents, and quality records Mentor junior engineers and provide guidance to QA technicians Contribute to continuous improvement and cost/waste reduction initiatives. What You Bring Bachelor's degree in Engineering or related technical field 4-6 years of experience in a quality role (medical device or regulated industry preferred) Strong experience in CAPA, nonconformance management, and root cause analysis Hands-on validation experience (IQ/OQ/PQ, test method validation) Knowledge of

ISO 13485, ISO 14971, FDA

QMSR, MDSAP, and EU MDR Experience with supplier quality and risk management Proficiency in data analysis and statistical tools (Minitab preferred) Strong technical writing, communication, and project management skills Ability to work independently and manage competing priorities Preferred ASQ Certification (CQE, CQA, SSBB, etc.) Lead Auditor experience Experience supporting audits and regulatory inspections Why Join Us Work on meaningful medical device products that impact patient care Collaborate with cross-functional teams in a growth-focused environment Opportunity to lead initiatives and drive measurable quality improvements Additional Information Work environment: Office-based with cross-functional collaboration

Travel:

Minimal (~10%) 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.