QMS-Medical Devices
3 weeks ago
Job Description
Company Description
Established in 1984, BL Lifesciences is part of the 75-year-old BL Group of Companies. Recognized as India's leading manufacturer and distributor of disposable devices, we specialize in Anesthesia, Critical Care, Cardiovascular Surgery, Interventional Procedures, Dialysis, and Respiratory Care. With 31 years of valuable experience, we are committed to delivering the highest quality services to the global medical industry. Our advanced and modernized devices ensure satisfaction among healthcare providers and foster strong, cordial relations.
Role Description
This is a full-time hybrid role for a QMS-Medical Devices professional. The role is located in Sadar, but allows for some work-from-home flexibility. The responsibilities include overseeing the quality management system for medical devices, ensuring compliance with regulatory standards, conducting internal audits, and coordinating with cross-functional teams to implement quality improvements.
- EXPOSURE OF ISO 13485 & EU MDR IS MANDATORY FOR THIS ROLE
- Knowledge of PMS, Risk Management
- Should have prepared EU MDR Documentation
- More exposure should be in QMS-RA (Regulatory)
- Knowledge in Medicine, Cardiology, and Treatment
- Experience in Orthopedic Surgery and Neurology
- Strong understanding of quality management systems and regulatory compliance
- Excellent problem-solving skills and attention to detail
- Bachelor's degree in a relevant field; advanced degrees or certifications are a plus
- Ability to work independently and in a hybrid work environment
- Effective communication and teamwork skills
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