ROLE AND RESPONSIBILITIES:
JUUL Labs is looking for a Senior Quality Engineer to join our Quality Systems team. Reporting to the Senior Manager, Quality Systems, they will assist in the implementation, management and continuous improvement JUUL Labs' Quality Systems to map with Quality System Regulation (§21 CFR 820) and ISO 13485, in addition to any applicable Federal and State compliance requirements specifically for Tobacco products. They will be responsible for assisting in the development of a compliant Quality Systems program and quality documents, and for assuring that quality data generated and submitted to regulatory agencies are valid and correct. Additionally, the Quality Engineer II must be able to guide and manage Quality System stakeholders through times of ambiguity and change, while maintaining support to business objectives.
Within a framework of ISO 13485:2016 and FDA 21 CFR parts 820/210/ 211, the individual will:
PERSONAL AND PROFESSIONAL QUALIFICATIONS: