Senior Quality Engineer (Medical Devices) Onsite
AccessHealth · San Diego, CA · 2 mo ago
Quality AssuranceContract
About the role
This contract role focuses on enhancing the quality and compliance of the Dispensing Implementation process in a medical device environment.
Responsibilities
- Evaluate processes against regulatory standards such as CFR 820.200, ISO 13485, and ISO 14971.
- Lead cross-functional improvement initiatives to ensure compliance and quality.
- Ensure documentation compliance for all processes and procedures.
- Drive efficient installation and implementation of medical device products.
- Communicate effectively with leadership and adhere to quality procedures.
Requirements
- Bachelor’s degree in engineering.
- At least 10 years of experience in FDA-regulated quality roles.
- Demonstrated success in compliance improvement projects within the medical device industry.
- Experience with medical device installation and embedded software.
- Knowledge of quality tools and methodologies.
Skills
- Strong organizational and communication skills.
- Ability to work effectively in cross-functional teams.
- Proficiency in regulatory standards (CFR 820.200, ISO 13485, ISO 14971).