Avinash P.
Quality Engineer |Risk Management| NPI| Minitab| Test Method Validations|
- Role
- Research and Development Engineer at Rheem Manufacturing Company
- Location
- Grand Rapids, MI, US
- LinkedIn followers
- 500 followers
About Avinash P.
Engineering Professional with 8 years of experience in Lean Manufacturing, Internal…
Experience
Research and Development Engineer
Jul 2025 — Present · Fort Smith, AR, US
Developed project plans for assigned product responsibilities, integrating Design Control deliverables and ensuring compliance with regulatory and quality requirements.• Led end-to-end design and development of new products from Concept to Launch, defining objective, measurable, and verifiable product requirements.• Managed CAPA and Nonconformance (NC) investigations, performing root cause analysis and implementing corrective and preventive actions in accordance with FDA, ISO standards, and QMS protocols.• Supported FDA inspections, internal audits, and compliance initiatives by maintaining documentation aligned with Quality Management System (QMS) standards.• Monitored and reported Quality KPIs, analyzing trends to recommend improvements that enhance QMS processes and overall product quality.• Assisted in FDA remediation and recall activities, ensuring timely resolution of compliance gaps with proper QMS documentation.• Partnered with manufacturing and supply chain teams to resolve quality issues, implement manufacturing process development and qualification, and drive continuous improvement initiatives.• Created, evaluated, and approved design changes, component specifications, and drawing releases, ensuring adherence to engineering and regulatory standards.• Reviewed product designs for compliance with engineering principles, company standards, customer requirements, and supplied component specifications, including vendor qualification and sampling plans.• Developed and executed Design Verification and Validation (DV/DA) protocols, including test method development and validation, to ensure products meet design requirements.• Conducted risk management activities, including FMEA and risk assessments, collaborating with risk managers and cross-functional engineering teams to mitigate safety hazards.• Supported Design for Manufacturing (DFM) initiatives to optimize designs for production efficiency, cost-effectiveness, and scalability.
Education
University of Central Missouri
Master's degree
2015 — 2017
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