• Support R&D, Manufacturing Department to ensure compliance with quality system policies and procedures, FDA and international requirements, and ISO Standards for Medical Devices
DUTIES & RESPONSIBILITIES:
• Experience in setting up Quality Management system and understand ISO 13485/14971/IEC 62304 / QSR requirements.
• Support documentation for CAPA analysis / Closure, Change Management & related QA activities.
• Ability to Perform Gap Assessment of QMS / Includes forms with respect to the following requirements.
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Deegit Inc focuses on lab test engineering, specifically within the medical domain.