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 RoleWe 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.
