Sharath A

+91-7619319348
sharathashoke@gmail.com
Sharath Ashok
Bangalore, India

SENIOR QUALITY ENGINEER

I'm a highly experienced Medical Device Manufacturing & Design Quality Engineer (Certified ASQ-CQE)
with 7+ years of expertise in Manufacturing, Quality, Supply Chain and Design Quality. I have driven high
impact Product Quality, Process Efficiency, and Regulatory Compliance deliverables. I specialize in LEAN
process improvements, Identify and deliver high value Process Simplification & Cost Saving projects,
100% Adherence to KPIs. Quality Systems, CAPA solutions, and ensuring Safety and Quality via Risk
Management, Design Verification & Validation. I'm a strong team player (with keen focus on SQDCP -
Safety | Quality | Delivery | Cost | People) with a keen eye for detail, looking to contribute to a forward-
thinking medical device company's success and growth.
SKILLS
ISO 13485 Production Management Leadership
Risk Management Change & Inventory Management Quality Management System
Problem Solving - DMAIC Lean | Six Sigma (LSSGB) Audit - Compliance
Product Management Design For Six Sigma (DFSS) ISO | MDSAP | FDA | MDR
Defect Management Statistics (DOE | Sampling | Ppk) Conflict Resolution
Quality Plan Environment Health & Safety Critical Thinking
Design Controls & Design Change Team Building Effective Communication

PROFESSIONAL EXPERIENCE
Senior Quality Engineer 2022 - Present
Becton Dickinson Technology Campus India | Medication Delivery Solutions (MDS) |
Catheters (PICCs, CVCs, ACVCs, Ports & IOs-Intra Osseous)
Led Design Change Implementation, Risk Management, Verification, and Validation efforts for sustaining
Engineering Projects, ensuring compliance with industry standards and regulations. Actively collaborated in 8
high impact project with R&D, Ops, Medical Affairs, Product Marketing, Regulatory, Materials, Packaging and
other cross functional teams.
Collaborated to establish User Requirements, Human Factors Assessments and Inspection Sampling studies
using analytical and statistical methods.
Reviewed and updated Risk Management Documents, ensuring accuracy and completeness to maintain a
robust quality management system.
Served as the Lead Auditee for internal and external certification audits, successfully demonstrating adherence
to quality standards and driving continual improvement. Completed audits with zero Non-Conformances.
Facilitated effective communication and collaboration between Manufacturing and cross-functional teams to
execute Sustenance Change projects, achieving 100% alignment with QMS.
Spearheaded Design Control and production/process control projects, ensuring compliance with all applicable
regulatory requirements and industry best practices.
Demonstrated exceptional leadership in Team Building activities for the entire quality group, fostering a culture
of continuous learning, improvement and mutual support to achieve team & organizational goals.

Product and Process Quality Engineer - Manufacturing & Equipment 2020-2022

GE Healthcare | Maternal Infant Care (MIC) - Warmer, Phototherapy,
Resuscitation Devices | Finished Medical Devices (FMD)
Achieved first pass yield (FPY) exceeding 98%, maintaining compliance at 100%, with zero non-conformances in
external audits across 5 product Manufacturing Lines.
Piloted Lean Productivity drives (Action Workouts), which led to 30% increase in operational efficiency.
Automated Test Equipment improvement via Process Validations. Single Piece Flow Line establishment.
Successfully led and effectively implemented 6 critical Manufacturing Site level CAPAs. Utilizing Root Cause
Analysis, identifying concerns across site and implemented systemic fix via Corrective & Preventive Actions.
Seamlessly established process controls for preventive actions, ensuring proactive measures to maintain product
quality and compliance.
Acted as the Single Point of Contact (SPOC) from the Quality team for key op-mechs, including Document Review
Board, Change Review Board, and Management Review Board.
Maintained a perfect track record with 100% Shipment Completion on time (SCOT) for all 5 products, quarter on
quarter.
Received outstanding results in audits, completing 3 MDSAP, 5 TUV, and 1 EHS excellence audits with zero non-
conformances and findings for two consecutive years.
Streamlined the Quality Management System using Lean principles, achieving a quick turn around with sustenance
and earning the tag of 'Simplified yet Compliant.'
Element Owner of Ergonomics EHS, leading 17 improvement projects, including Management of Change (MOC)
initiatives.
Played a crucial role as a liaison between design and manufacturing, successfully executing 4 New Program
Introductions. Authored Inspection Plans | Process Flow | Manufacturing SOPs | Preventive Maintenance SOPs |
Defect management | Rework Procedures | MSA study and Go No-Go Gauge Implementation.
Demonstrated dynamic Cross-Functional Team engagement, implementing Kaizen projects 3X times faster.

Manufacturing Change Coordinator- Extended responsibility 2020-2022

Liaison between Design center and Manufacturing for time-bound and compliant implementation of design
changes.
Breakthrough process improvement - Via CAPA - Design change closure rate across site increase by 17% -
Systemic fix - Zero miss.
Successfully Closed legacy records >600 design changes across all products via Corrective Actions and Preventive
Actions path.
Weekly Change control op-mech - ensured zero delays in design change implementations with zero scrap & zero
non-conformance.
Implemented >75 ECOs(Engineering Change Orders) year on year with seamless phase-in phase-out (PIPO) and
first-in first-out (FIFO) strategies.
Manufacturing Engineer 2018-2020
GE Healthcare | X-Ray | CTs | Tubes Subsystem Manufacturing
Responsible for Product Quality | compliance | yield of Metal Parts Processing shop with 9 furnaces (dry and wet
hydrogen firing furnaces | degassing vacuum furnaces)
Data analysis and yield improvement in processes of Brazing, Welding, Machining(CNC, VMC and WEDM), Vacuum
firing, degassing, oxidizing and inspection processes.
Calibration core team member, Authored OOTs, OOSs, Deviations and impact analysis via CAPA.
Successfully completed 2 MDSAP audits and 5 internal audits with zero non- conformances.
Piloted 2 New Program Introductions as part of Design Transfer. Collaborated with Cross Functions to seamlessly
implement Manufacturing Process Flow, Incoming Inspection Plans, Process Validation and streamlining the
critical dimensions measuring process.
Graduate Engineering Trainee 2016-2018

Supported Product Quality metric (KPIs) up-keep across 4 sub-shops

Adept at Residual Gas Analysis and Forward Looking Infrared Camera Analysis - FLIR
Scrap reduction projects implemented ~$70k and 650Hrs saved annually
Initiated Big Talks - Forum for GETs to learn share and interact with functional leaders

EDUCATION 2012-2016
BE | MECHANICAL ENGINEER
Nitte Meenakshi Institute of Technology | VTU
8.34/10.0 - CGPA
12th - Pre University 2010-2012
St. Joseph's Pre-University College
84.5%

AWARDS CERTIFICATES
Impact Award for Breaking Barrier from the Managing Director ASQ-CQE
Empower and inspire award for seamless CFT engagement in Lean Six Sigma Green Belt (DMAIC)
program execution Design for Six Sigma Green Belt (DFSS)
Focus Award from management for supply chain simplification German Language A2 certified
Impact Award for delivering with focus
Award from GM for seamless FMI execution
Milestone award for commitment to GE
EHS executive award for safety-ergo reduction