Complaint handling and Product investigations of medical devices
Root cause analysis of field returned products
Understanding on Medical Device Risk Management
Understanding of Medical Device Design Controls & Change Controls
Understanding of New Product Development (NPD) Cycle
Experience with TrackWise and Microsoft Project
Experience on Post Market Surveillance as per US FDA & EU MDR
Experience on Quality Management (ISO 13485 or 21 CFR 820)
Understanding on Medical Device Risk Management
Ability 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 institutes
4-5 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.
