Quality Engineer

Work Flexibility: Hybrid

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.

Travel Percentage: None