Quality Engineer II (Electronics)

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%)