Quality Engineer
Location
Scottsdale, AZ
Level
Mid-Level
Department
MedTech
Type
Salary
Job Description
Posted on:
2025-09-01
Responsibilities
- Ensure compliance with FDA and ISO standards.
- Support new product development initiatives with quality assurance.
- Provide documentation for FDA 510K submissions.
- Participate in risk management activities and conduct PFMEA risk assessments.
- Develop and write test methods and documentation for manufacturing processes.
- Conduct data analysis and support continuous process improvements.
- Train manufacturing/QC personnel on test methods or processes.
Job Requirements
- Bachelor's degree in a technical field (Bioengineering, Electrical Engineering, Mechanical Engineering, etc.).
- Minimum of three years of experience in quality engineering.
- Knowledge of Medical Device QMS and regulatory requirements (FDA CFR 21 820, ISO 13485).
- Proficiency in risk management and statistical analysis using Minitab.
- Ability to write technical documents and communicate effectively.
- Experience in training personnel.
- Self-motivated and able to work independently.
