Quality Engineer Chemical Engineering

Snehal Rajesh Rane, CQE

Medford, MA ***** ************@*****.*** 716-***-**** www.linkedin.com/in/snehalr SUMMARY

Quality Engineer with 5 years of experience in Product Development Life Cycle, ISO and FDA Audits, Risk Management, and implementation of lean processes using six sigma tools. SKILLS

Quality Assurance Lean Methodologies Statistical Process Control Six Sigma SAP

Process Validation Process Development Medical Device Reporting Fishbone CAPA

Master Control Risk Management Process Capabilities Salesforce DMAIC

21 CFR 21, 820,211,210 Minitab Supplier Quality ISO 13485 Audits PROFESSIONAL EXPERIENCE

Quality Engineer,

ECRM Imaging Systems, N. Andover, MA July 2018 – Present

Enabled an 85% increase for Rebion's blinq (Pediatric Vision Scanner) production while maintaining cost and quality targets to meet increased demand.

Improved product yield 25% and reduced customer returns by 20% by intensive troubleshooting of existing manufacturing and engineering processes.

Coordinated with cross-functional teams for implementation of Quality System compliant with ISO 13485

Successfully led FDA and ISO audits by establishing a highly effective Internal Audit and CAPA program.

Developed a risk-based inspection process focusing on the highest risk dimensions and attributes.

Lead Material Review Board (MRB) to recommend disposition and corrective action.

Oversee supplier qualification, SCARS and monitoring of supplier performance using supplier score card. Quality Engineer II

Arsenal Medical, Watertown, MA September 2017 – April 2018

Quality lead for ResQfoam, Sac Filling System for Abdominal Aortic Aneurysms, and Sinus Drug Depot.

Product development SME for quality standards, design control requirements and regulatory requirements.

Led Internal Audits and Gap Analysis to update the QMS from 13485:2003 to 13485:2016. Quality & Regulatory Affairs Specialist

Medtronic, North Haven, CT January 2017 – September 2017

SME for global reportability decision and reports for Europe, Canada, Australia, China, and Japan.

Increased FDA reporting timeliness to 97.5% by closely monitoring timeliness of complaint files using the SAP Global Complaint Handling System (GCH).

Reviewed medical summaries and provide trends with cross functional departments. Quality Engineer / Technical Writer

West Pharmaceutical Services, AZ April 2015 – November 2016

Led the team to harmonize procedures for Risk Management, Validation and Change Control across 7 sites.

Process Mapping for current and future state to outline the scope of the project.

Improved validation processes for semi-automated equipment, increasing efficiency from 92% to 99%.

Validated and qualified processes and assembly lines for SmartDose 3.5 and Dexcom Glucose monitoring device.

Participated supplier certification and assessment audits to ensure compliance to required regulations. EDUCATION

University at Buffalo, The State University of New York

Master of Science in Chemical Engineering June 2014 University of Mumbai, India

Bachelor of Engineering in Chemical Engineering December 2012 CERTIFICATION

−− Certified Quality Engineer - American Society of Quality Certification number: 101543 February 2018

Contact this candidate