Shiney S
Product Complaint Reporting & Analysis | Advanced Sterilization Products | Post Market Surveillance | Patient & Product Safety | EU-MDR | 21 CFR 803 | 21 CFR 820 | ISO-13485
- Role
- Customer Quality Specialist at Advanced Sterilization Products
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Shiney S
Detail-oriented Quality and Regulatory Affairs Professional in the medical device…
Experience
Customer Quality Specialist
Advanced Sterilization Products
Apr 2025 — Present
Assess and determine reportability for OUS regulatory authorities for product complaints, ensuring strict compliance with international quality standards.• Manage distributor complaint cases in the company’s centralized complaints management portal, overseeing all aspects of case documentation, follow-up, and resolution.• Perform trend analysis of complaint data using the Incorta dashboard, identifying emerging quality concerns and supporting post-market surveillance initiatives.
Education
Bharathi Vidhyalaya Matriculation Higher secondary school, Namakkal
10th Grade
2015 — 2016
College of Engineering, Guindy
Bachelor of Engineering - BE
2018 — 2022
Bharathi Vidhyalaya Matriculation Higher secondary school, Namakkal
12th Grade
2017 — 2018
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