Sagar A.
Quality Engineer | ASQ CQE | ISO13485 Lead Auditor | NPI & Validation Expert | Medical Devices | Driving Product Quality & Compliance | CAPA, Risk Analysis, Supplier Qualification
- Role
- Quality Engineer Npi at Phillips Medisize
- Location
- Grafton, MA, US
- LinkedIn followers
- 500 followers
About Sagar A.
As a results-driven Senior Quality Engineer with over 8 years of experience in the…
Experience
Quality Engineer Npi
Apr 2022 — Present · Clinton, MA, US
Led validation activities for 10+ new product introductions, ensuring FDA and ISO compliance- Developed and executed validation protocols and reports, reducing process variability by 15%- Managed CAPA and NCMR investigations, successfully closing 95% within target timelines- Drove supplier qualification and corrective actions, improving supplier performance metrics- Collaborated with cross-functional teams to deliver quality improvement projects and audit readiness-Mentored Junior Engineers to train them as a Succesful Quality Engineer
Education
Gurunanak Institute Of Technology
Bachelor's degree, Mechanical Engineering
Texas A&M University-Kingsville
Master's degree, Mechanical Engineering
2016 — 2018
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