- Complaint handling and Product investigations of medical devices
- Perform Visual, Functional and Dimensional inspection of returned products.
- Root cause analysis of field returned products
- Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities.
- Risk management - Risk assessment
- Review of design and process documents for root cause analysis
- Review of Process flow, DHR, inspection plans, measurement techniques, GRR's etc.
- Review and analyze Literatures such as Clinical Reports, PMCF Reports etc. to identify Complaints
Required Experience, Skills and Qualifications Experience : 3-7 Years
- Sound knowledge on complaint handling process of medicaldevices
- Hands on experience of problem solving methodology and root cause analysis
- Valuable Understanding of Risk Management process
- Strong Analytical ability.
- Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have).
- 7 QC tools, Problem Solving & CAPA.
- Demonstrated auditing experience in a manufacturing environment.
- Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.
- Demonstrated organizational and written/verbal communication skills.
- Demonstrated ability to self-motivate
- Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
- Demonstrated ability to prioritize tasks in a deadline-driven environment.
- Hands on Experience of Complaint handling and product investigations process
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Benefits
Best in Industries
Job Type: Full-time
Pay: ₹30,000.00 - ₹35,000.00 per month
Work Location: In person
📌 Wanted Sr Quality Control Engineer Cum MR (Perungudi)
🏢 Lubdub Medical Technologies
📍 Perungudi
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