Quality Manager - Medical Devices

Company Description

Criador Labs is an award-winning product design and innovation firm that specializes in transforming ideas into impactful solutions. With a track record of completing over 100 client projects and producing more than 50 prototypes, the company applies cutting-edge technology to drive success. Serving clients ranging from start-ups to Fortune 500 companies, Criador Labs operates across healthcare, consumer, and commercial industries. By leveraging expertise in research, technology, design, engineering, and manufacturing, Criador Labs delivers innovative, effective, and sustainable results. Learn more at www.criadorlabs.com.

Role Description

This is a full-time, on-site role for a Quality Manager in Medical Devices, based in Bangalore Urban. The Quality Manager will be responsible for overseeing and improving quality management systems, ensuring products meet regulatory and industry compliance standards, and coordinating quality assurance activities. The role will involve process improvements, product audits, documentation control, and driving quality metrics. The candidate will also collaborate with cross-functional teams during product development and manufacturing stages and ensure regulatory audits and certifications are managed effectively.

Qualifications

• 1-3 years of Experience.
• Strong knowledge of quality management systems, compliance protocols, and regulatory frameworks in the medical device industry.
• Proficiency in standards such as ISO 13485, FDA regulations, and risk management strategies like ISO 14971.
• Experience with quality assurance processes, process audits, and quality control techniques.
• Excellent documentation management and record-keeping skills, particularly in the context of technical files and regulatory submissions.
• Strong analytical and problem-solving skills with attention to detail.
• Effective communication and leadership abilities to work collaboratively with cross-functional teams.
• Bachelor’s Degree in Engineering, Science, or a related field; advanced certifications in quality management or regulatory affairs are a plus.
• Experience in the medical device or healthcare product development industry is highly desirable.