Quality Assurance Manager

Company Description Medorah Meditek Pvt. Ltd., founded in 2016 in Gurugram, designs and manufactures innovative medical devices that address conditions of the digestive and pulmonary systems. The company focuses on gastrointestinal disease states such as esophageal disorders, GI strictures and bleeding, biliary diseases, and cancers of the esophagus, biliary tract, pancreas, and colon. Medorah Meditek has become a pioneer in India in the development and manufacturing of Self-Expandable Metallic Stents (SEMS) and offers a broad portfolio including guidewires, plastic stents, hemostatic devices, self-expandable metallic stents, forceps, and other minimally invasive products. The organization promotes a collaborative, innovation-driven culture with a clear purpose: improving lives by making healthcare accessible. Team members are supported through investment in their well-being and are encouraged to make a meaningful impact on patients and communities.

Role Description The Quality Assurance Manager is a full-time, on-site role based in Gurugram. This role is responsible for overseeing quality systems and processes across the design, development, and manufacturing of medical devices, ensuring compliance with applicable regulatory, statutory, and industry standards. Day-to-day responsibilities include establishing and maintaining quality procedures, supervising inspection and testing activities, reviewing and approving documentation, and leading internal and external audits. The Quality Assurance Manager collaborates closely with R&D, manufacturing, regulatory, and supply chain teams to investigate non-conformities, drive root cause analysis, and implement corrective and preventive actions. The role also involves training team members on quality best practices, monitoring key quality metrics, and continuously improving the quality management system to support product safety and effectiveness.

Qualifications

• Strong knowledge of quality management systems and standards for medical devices (e.g., ISO 13485, GMP, relevant regulatory requirements).
• Experience in quality assurance, quality control, and process validation within medical device or healthcare manufacturing environments.
• Proficiency in documenting and managing SOPs, work instructions, and technical records, with attention to detail and accuracy.
• Ability to lead audits, manage risk assessments, and drive root cause analysis, CAPA, and continuous improvement initiatives.
• Solid understanding of manufacturing processes for minimally invasive devices, materials, and product testing methods.
• Excellent analytical, problem-solving, and decision-making skills, with capability to handle multiple projects and priorities.
• Effective communication and collaboration skills to work cross-functionally with engineering, production, regulatory, and supply chain teams.
• Bachelor's or Master's degree in Engineering, Quality, Biomedical, or a related technical field; relevant certifications in quality or regulatory affairs are an advantage.
• Prior experience in a leadership or managerial