Lead QMS

4 weeks ago

Bengaluru, Karnataka, India Ai Health Highway Full time
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 Turbostart, Rainmatter by Zerodha, The Chennai Angels, Social Alpha (Tata Trusts) & many other marquee investors. We have been part of global accelerators Maine Technology Institute (US) Sound Hub (Denmark) Foundation for Science, Innovation and Development (FSID) IISC Bangalore, CDL Montreal (Canada).

AiSteth is India's first Ai-enabled Smart Stethoscope & we have screened more than 56,000+ patients across 20+ States of India within 18-24 months of launch.

Goal - Our Goal is to reduce 30% premature deaths due to #NCDs by 2030.

We are looking to hire a Lead QMS who has hands-on experience in implementing QMS, ISO13485, EU MDR, US FDA (510k) Risk Management processes for Medical Devices . The Lead QMS will engage with both internal and external stakeholders and set up quality management & regulatory framework for the product pipeline in the organization.

JOB DESCRIPTION

● Lead QMS & Risk Management initiatives

● 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

● Liaise with external consultants and internal team to help with documentation preparation for the US FDA (510k) and EU-CE Marking regulatory submissions.

QUALIFICATIONS & SKILLS

● 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/ISO 14971 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

● Trained Internal Auditor

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