Job Details
What you will do- What you will need- Required-
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. - 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
- 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.
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