Job Overview
We are seeking a Principal Quality Engineer to join our organization.
Key Responsibilities
* Develop and maintain quality systems in compliance with ISO 13485:2016 and the quality system regulation 21CFR Part820.
* Manage document control, represent the quality function at functional team meetings and support teams in meeting objectives.
* Participate in risk management, liaise with technical operations and prepare quality system metrics.
* Address customer complaints, manage CAPA systems and maintain internal audits.
* Support supplier management and continuous improvement initiatives.
Requirements
* Bachelor's degree in Science or Engineering.
* Eight years of experience in quality engineering or regulatory roles, preferably in the medical device industry.
* Excellent communication and presentation skills with the ability to effectively present information.
* Able to prioritize and focus on critical objectives.