Quality Assurance Manager

Company Description

D&D Healthcare is India's largest ventilator manufacturing company, dealing in various ICU equipment such as DVT Pumps, Suction Pumps, and various types of ventilators. Established in 2018, it is one of the fastest-growing Indian healthcare startups. The R&D center is located in Noida, spread over half an acre, with the capability to develop high-end ICU equipment quickly. D&D Healthcare provided the largest number of ventilators by a private organization to the Indian Government during the COVID pandemic.

Role Description

This is a full-time on site role for a Quality Assurance Manager. The Quality Assurance Manager will be responsible for overseeing quality assurance processes, developing and implementing quality management systems, conducting audits, ensuring regulatory compliance, and managing a team of quality assurance specialists. The Manager will also analyze data to identify areas for improvement and ensure the continuous improvement of products and processes.

Qualifications

• Experience in Quality Assurance and Quality Management Systems
• Skills in conducting audits and ensuring regulatory compliance
• Strong analytical skills to identify areas for improvement
• Team management and leadership skills
• Excellent written and verbal communication skills
• Ability to work independently and remotely
• Experience in the healthcare or medical device industry is a plus
• Bachelor's degree in Engineering, Science, or related field

Must Have

• Experience in certification of Class 2B and Class C Medical devices
• Minimum experience of at least 5 years in the field of QA/QC
• Knowledge of Electronics and Programming
• Managed a team of at least 5 members
• Knowledge of ISO 13485, IEC 60601, IEC 80601
• Should be aware of process of CE FDA & CDSCO