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Gurugram, 122001, IN
Job details
Work flexibility: Hybrid
Req ID: R537501
Employee type: Full Time
Job category: Engineering
Travel:
Relocation: No
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Job description
What You will do:
- 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.