Jishnu S
Bridging Compliance & Innovation | Quality Engineer | CQI IRCA Certified ISO 13485:2016 Lead Auditor | ISO 9001 | ISO 14971 | Supplier Quality | Document Control | Lean Six Sigma |Passionate About Continuous Improvement
- Role
- Quality Compliance Engineer at Lumin Innovations
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Jishnu S
Experienced Quality Engineer with a proven track record in the medical device industry, specializing in Quality Management Systems (QMS), ISO 13485 compliance, EU MDR, FDA regulations, and ISO 14971-based risk management. Skilled in product quality evaluation, documentation control, complaint handling, and post-market surveillance. Adept at ensuring regulatory compliance while driving continuous improvement across cross-functional teams. Holds a Bachelor of Technology (BTech) in Mechanical Engineering from Kerala University, with a strong commitment to quality, safety, and operational excellence.
Experience
Quality Compliance Engineer
Aug 2023 — Present · Hyderabad, IN
Quality Engineer | Lumin InnovationsMedical Device Industry | ISO 13485:2016 | Quality Systems | Supplier Quality ManagementDriving QMS remediation initiatives to strengthen regulatory compliance and align the organization with ISO 13485:2016 standards.Authoring and revising Quality System documentation, including Standard Operating Procedures (SOPs), Work Instructions, and Manufacturing Procedures, to support operational excellence.Supporting and participating in internal and external audits, contributing to audit preparation, execution, and timely closure of findings through corrective and preventive actions (CAPA).Facilitating change control processes by ensuring structured implementation of quality improvements across procedures and records.Managing supplier quality activities, including supplier evaluations, audit support, and corrective action follow-up to enhance supplier performance and compliance.Promoting a culture of continuous improvement by identifying process enhancement opportunities and driving cross-functional collaboration.Enabling effective training and compliance monitoring initiatives to support QMS adoption across teams.
Education
University of Kerala
Bachelor of Technology - BTech
2013 — 2017
Amrita Vishwa Vidyapeetham
Master of Business Administration - MBA
2024
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