Manager - Medical Quality Assurance - ISO 13485, CE, FDA

Location

Bangalore | India

Job description

Company Description

Prodancy is a medical device startup located in Bengaluru, developing products for respiratory protection devices such as Surgical helmet for Orthopedic Surgeons. We combine our 23 years of product design experience with the latest technologies, to solve problems impacting healthcare professionals.

Role Description

This is a full-time on-site role for a Manager - Medical Quality Assurance - ISO 13485, CE, FDA. The Manager will be responsible for developing and maintaining the company's quality management system in compliance with ISO 13485, CE, and FDA regulations. They will also lead the Quality team in ensuring that products meet quality requirements and customer expectations.

Qualifications

• Bachelor's degree or higher in a relevant field
• Minimum 5 years of experience in Quality Assurance in a medical device
• Experience with ISO 13485, CE, and FDA 510K regulations
• Experience in managing a team
• Experience in conducting internal and external audits
• Excellent knowledge of Quality Assurance, Quality Control, and Quality Management Systems
• Excellent communication and leadership skills
• Strong attention to detail and problem-solving skills
• Ability to work under pressure and meet tight deadlines

If you meet these qualifications and are passionate about developing innovative healthcare products, we encourage you to apply.

Job tags

Salary