Quality Engineer Medical Device

RASHMI

917-***-**** adlcvb@r.postjobfree.com

SUMMARY

A highly efficient Quality Engineer with demonstrated history of working in Medical device industry

Huge knowledge of cGMP and ISO standards of medical and pharmaceutical devices

Professional experience in the Medical device industry with expertise in validation of documents and equipment used in manufacturing.

Knowledgeable in medical device design controls including, but not limited to: development planning, design input requirements, risk management, design reviews, design output, and DHFs. Familiarity with the 21 CFR 820 QSR.

EDUCATION

Visweswaraya Technological University

Karnataka, India

Bachelor of Engineering in Computer Science

2013-2017

CORE COMPETENCIES

Quality Management

Project Co-ordination

Document Review and Management

ISO 9001, ISO 13485

MS Office applications

TFS, SAP DMS

MDR 2017/745

Leadership and Communication

Attentive to details

EXPERIENCE

Siemens Healthineers (Business partner: ManpowerGroup Services India Pvt. Ltd.) Karnataka, IN

Quality Engineer Dec 2017 – Sep 2019

Handle the release activities for Siemens software products from initialization till end of the project

Auditing the project steering and engineering documents, ensuring findings are closed prior to release

DMR/DHF incoming inspection

Participating in CCBs and assigning the defects to respective stakeholders

Good knowledge on EU MDR and MDR reporting, complaint handling process, Reporting of Adverse Events & Field Safety Corrective actions

Performing of Main Reviews (R-Reviews) as project milestones

Responsible for Quality process and authorship of Quality Management Plan (QMP) and Document Plan (DP)

Ensuring compliance of products as per SY PLM and SHPL QMS requirements

Ensure awareness for quality focus to increase customer satisfaction throughout the project life cycle

Perform root cause analysis and implement corrective action for process related concerns

Support in process management activities for process definition, process improvement and process training

Co-ordination with Quality Manager and Project lead on various SHPL QMS related activities

Develop training to build quality awareness and training to project teams on quality and process topics

Support configuration manager on long term archival of the medical artifacts

TRAININGS AND CERTIFICATIONS

Overview Program on ISO 13485: 2016 -Medical Devices Management System - TUV NORD GROUP

EU MDR explained in simple terms - Udemy

Mini-course on MDR 2017/745 - easymedicaldevice.com

How to maintain a QMS compliant to MDR & IVDR

Six Sigma: Green Belt - LinkedIn

Quality Management foundations, Project Management Foundations and lean foundations - LinkedIn

Overview of ISO 9001:2008, ISO 9001:2015 internal - siemens

QMS Training @ HC SI DC IN - Siemens

LEADERSHIP

The iCare group – Bangalore, IN

Marketing Head & Campus Ambassador (Gulbarga wing) Jan 2015 – May 2017

Conducted events and served specially privileged people in this student driven organization which is aimed at providing community service and skill development.

Started the branch of this same group for social service which included ~100 volunteers and was responsible for providing basic education for special kids.

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