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.

Allen, TX | Full-Time

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.

• 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

• 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

• 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

Work environment:
Office‑based with cross‑functional collaboration

Travel:
Minimal (~10%)