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Quality Engineer - PMS

Stryker

2.0 - 5.0 years

0 Lacs

Gurugram, Haryana, India

On-site

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 wit...

Posted 3 days ago

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