Quality Engineer III
Location
Plano, TX
Level
Senior-Level
Department
MedTech
Type
Salary
Job Description
Posted on:
2025-09-03
Responsibilities
- Drive new product design and development activities.
- Lead the transition from product design to production.
- Oversee manufacturing and quality activities for improvement and risk management.
- Implement quality initiatives and manage post-market activities.
- Conduct root cause investigations and corrective actions.
- Develop and implement quality management system procedures.
- Participate in internal and external audits.
Job Requirements
- Bachelor’s degree in engineering or a related field.
- Minimum of three years of experience as a Quality Engineer in the medical device industry.
- Knowledge of FDA QSR, EU MDR, and other medical device regulations.
- Proficiency in statistical analysis software, such as Minitab.
- Excellent communication and organizational skills.
- Ability to multitask and work in a team environment.
- Experience in supporting Design QE activities and process validation.
