Work Flexibility: Hybrid

What You will do:

Complaint handling and Product investigations of medical devicesRoot cause analysis of field returned productsUnderstanding on Medical Device Risk ManagementUnderstanding of Medical Device Design Controls & Change ControlsUnderstanding of New Product Development (NPD) CycleExperience with TrackWise and Microsoft ProjectExperience on Post Market Surveillance as per US FDA & EU MDRExperience on Quality Management (ISO 13485 or 21 CFR 820)Understanding on Medical Device Risk ManagementAbility to coach team members and develop them in role.Experience of working with multiple teams and collaborating across geographically spread multi-functional teams.

What you need:

Education and Experience:

BE/BTech/ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes4-5 years of experience in Medical Device domain. At least 2+ years of experience in complaint handling or customer quality.

Skills:

Strong analytical and problem-solving skills. Excellent written and verbal communication skills. Proficiency in QMS software and tools.

Nice to Have :

ISO 13485:2016 certification

Soft Skills  

Excellent communication & interpersonal skills. High analytical skills.Able to run communicate effectively with senior leadership. Excellent problem-solving skills. Proactive to support both internal and external customers.

Travel Percentage: None