Lead QMS & Risk Management initiatives

About Us:
Ai Health Highway is a MedTech start-up focusing on developing medical devices to screen, detect & predict Chronic Diseases using state of the art technology. We are backed by Maine Technology Institute (US), Sound Hub/Accelerace (Denmark) & currently incubated in SID/IISC (India). We are also recently shortlisted under Innovators Programme by Chiratae Ventures. Our investors include India’s leading social enterprise incubator backed by well known industrial group, marquee Global DeepTech accelerators from US, Denmark & India combined with some prominent angel investors with global impact stories.

Goal - Our Goal is to reduce 25% premature deaths due to #NCDs by 2025.

Role:
Lead QMS & Risk Management initiatives

Responsibilities:
  • Create device master records/design history files and update technical documentation and records
  • Develop product requirements /technical specifications based on the DHF gap assessment
  • Work with engineering & manufacturing teams to develop robust verification test strategies to ensure product safety and reliability
  • Provide inputs into design of products in development & support validation programs for new product development.
  • Work with cross-functional teams to develop regulatory guidelines and procedures
  • Review device labelling and advertising materials for compliance with regulations; analyze and recommend appropriate changes
  • Hands-on experience / understanding about US FDA Quality system regulations 21 CFR 820
  • Familiar with regulatory requirements for Medical Devices, including 510, regulatory submissions, Classification of Medical Devices

Requirments:
  • 3 to 5 years’ experience in Medical Device QMS and regulatory domain
  • BTech/BE in Electronics/Electrical/CS or Bio-Medical Engineering with experience in quality role in engineering /manufacturing environment
  • Prior experience in risk assessment for medical devices as per ISO13485/CE certification
  • Experience in Documentation, Review & Reporting areas & excellent interpersonal communication skills
  • Manage non-conformance, corrective action preventive actions and deviation
  • Conduct required QMS training to all employees and monitor the training coverage and effectiveness
  • Any additional knowledge / experience with EU MDR will be a plus