Quality Engineer - Post Market Surveillance

Quality Engineer - PMS

Work Flexibility: Hybrid

What you will do-

• Perform preliminary complaint intake, management, and event classification. 

• Conduct customer follow-ups and assess complaints for regulatory reportability in accordance with FDA 21 CFR 803, EU MDR 2017/745, and ISO 13485.  

• Prepare and submit MDR, MIR, vigilance, and global adverse event reports, achieving zero late submissions. 

• Collaborate closely with stakeholders and team members, providing guidance and coaching to drive engagement and performance. 

• Demonstrate strong knowledge of Post-Market Surveillance requirements (US FDA and EU MDR), Quality Management Systems (ISO 13485, 21 CFR 820), and complaint handling tools such as TrackWise or equivalent systems. 

• Experience with TrackWise and Microsoft Project ; Post Market Surveillance as per US FDA & EU MDR ; Quality Management (ISO 13485 or 21 CFR 820 ; working with multiple teams and collaborating across geographically spread multi-functional teams. 

• Understanding on Medical Device Risk Management 

What you will need-

Required-

• ​BE/BTech/ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes 

• Experience- 2years to 5 years

• ​1-2 years of experience in Medical Device domain; At least 1+ years of experience in complaint handling or customer quality. 

Preferred-

• ​ISO 13485:2016 certification​ 

• Strong analytical and problem-solving skills; ​excellent written and verbal communication skills and proficiency in QMS software and tools.

• Able to run communicate effectively with senior leadership. 

• Excellent problem-solving skills. 

• Proactive to support both internal and external customers. 

Travel Percentage: None

Experience Level

Executive Level