Position Title:

QA Executive

Reports to:

QA Manager

Location:

NCR

INTRODUCTION:

Company Profile:

Medorah Meditek Pvt. Ltd., established in 2016 in Gurgaon, develops and manufactures devices to treat an array of medical conditions including diseases pertaining to digestive and pulmonary systems. Common gastrointestinal (GI) disease states include esophageal disorders, GI strictures and bleeding, biliary disease and conditions, as well as esophageal, biliary, pancreatic and colon cancer.

At Medorah

Meditek, we work collaboratively to solve the toughest challenges in healthcare. We go above and beyond our mission of improving lives by investing in the future and the well-being of all our employees.

The collaborative culture at Medorah Meditek is driven by a passion for innovation and a mission to improve lives by making healthcare accessible and affordable by all. With determination, imagination and a deep passion for human life, we have become the pioneers in the field of development and manufacturing of Self-Expandable Metallic Stents (SEMS) in India. Our product portfolio includes catheters, wire guides, plastic stents, hemostatic devices, band ligators, forceps and other minimally invasive devices.

Medorah Meditek is a place where you can find a career with a purpose – improving people’s lives. When you become a part of Medorah’s family, you will see that reflected in everything that you do. If you are ready to make a difference in the community, there’s no better place to make it happen.

· Write and review SOPs and other quality assurance related technical data forms and quality documents

· Proper maintenance of control documents in Quality Assurance





· Control documents of different departments

· Review validation protocols for GMP compliance

· Assist in carrying out internal quality audits on company systems and documentations

· Assist in the development, maintenance and implementation of processes and procedures in accordance with regulatory requirements

· Establish that all manufacturing processes and procedures are in accordance with properly released documentation

· Coordinate and assist in corrective and preventive action activities and solutions

· Perform investigations on non-conformances and customer complaint close out and corrective actions

· Audit on-going vendors, systems and documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines

· Provide QA support and advice to internal and external clients

· Ensure the timely and effective follow-ups of all identified or assigned quality issues

· Maintains and demonstrates understanding of global standards, regulations and regulatory bodies to include but not limited to ISO13485

· Assist in the maintenance of Quality Management System

Requirements

· Minimum of 1.5 years of Medical device QA/RA experience

· Familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management preferred

· Conscientious and responsible

· A keen eye for detail and a results driven approach

· Solid communication and presentation skills.

· Excellent organizational and leadership skills

· Proficient in MS Office

· In depth understanding of quality control procedures and relevant legal standards

📌 Quality Assurance Executive (Gurugram)
🏢 Medorah Meditek
📍 Gurugram