Harish Shankar
Bangalore
Summary
Experienced Head of Quality with proven background in overseeing quality assurance departments, developing effective strategies, and implementing robust quality control programs. Showcases strong leadership skills, adept at fostering team collaboration and instilling a culture of continuous improvement. Notable impact includes improving product quality, enhancing customer satisfaction, and reducing operational inefficiencies.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Head of Quality Assurance and Regulatory Department
Innovation Imaging Technology Private Limited
01.2022 - Current
- Creating, managing, and issuing quality policy and procedures to ensure the organization's quality system is implemented and sustained.
- Managing and training the quality and regulatory staff to ensure they have the skills and knowledge to perform their roles and responsibilities effectively.
- Creating goals and objectives for cross-functional departments in line with organizational goals to improve product and process quality.
- Understanding regarding quality and regulatory-related information updates and communication to the organization to ensure identified gaps and new requirements are met.
- Providing direction, motivation, and guidance to the organization's quality improvement efforts.
- Responsible for EUMDR, MDSAP, USFDA, IMDR, AERB Type approval, NABL 17025, ISO 13485 compliance and certification, AERB commercial license for the finished medical device, and manufacturing site.
- Responsible for Regulatory Strategy and product registrations for international markets like Europe, USA, Kazakhstan, Malaysia, Bangladesh, Sri Lanka, Ethiopia, Ecuador, Philippines, and Latin American countries.
- Complaint handling and product quality trending through monthly operating mechanisms.
- Assessing and reporting Serious Adverse Events, Clinical Investigation plan preparation, and clinical trials for new products.
- Driving and leading Lean projects for site to improve quality, delivery, and reduce overall product cost.
- Formal Design Reviews for New Product and Significant Design Changes, responsible for reviewing, approving, and implementing design changes through effective production change control process and Engineering Change Review Board.
- Production Transfers and New Product Introduction to Company Portfolio.
- Responsible for the development, implementation, and continual improvement of processes/product quality through the CAPA process.
- Ability to lead external QMS/Audits and Inspections.
- Utilized Six Sigma and Lean Manufacturing for process enhancement
- Ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans.
- Responsible for establishing Incoming, In-process quality, and Final quality.
- Equipment Qualifications (IQ, OQ, and PQ) and Process validations.
- Supplier Evaluation, qualification, monitoring, and risk assessment for conditionally qualified supplier.
- Scheduling and conducting internal audits to monitor effectiveness of QMS system and CAPA.
- Responsible for Production and Process Controls (Verification and validation activities, PPC changes) at site.
- Responsible for EHS and OHAS implementation and certification (ISO 14001 and ISO 45001).
Senior Quality Assurance Leader
Wipro GE Healthcare Pvt Ltd
12.2010 - 01.2022
- Coaching and mentoring new team members on QMS, standards, and regulations.
- Established Quality Management System compliant with FDA, ISO 13485, and other regulatory standards
- Complaint handling and trending for assessing the need for corrective/preventive actions for product and process improvements.
- CAPA leader for site-specific modalities.
- Driving and leading Lean projects for site to improve quality, delivery, and reduce overall product cost.
- Formal Design Reviews for New Product and Significant Design Changes
- Reviewed and approved design changes with a structured process
- Production Transfers and New Product Introduction
- Development and implementation of site-level procedures.
- Responsible for the development, implementation, and continual improvement of processes through the CAPA process.
- Support External QMS product Audits.
- Review and Approval of Regulatory Clearance and Product Holds
- Development of process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, Brainstorming, MSA (Gauge R&R, Test Re-test), 7 QC tools, PFMEA, etc.
- Ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans
- Set up Incoming, In-process quality, and Final quality.
- New product introduction through effective line validations, qualifications, and verification
- Supplier qualification and risk assessment for conditionally qualified supplier.
- Conducted inspection readiness activities for FDA, MDSAP country regulations, and external audits.
- Scheduled internal audits at specific intervals.
- Managed production controls including verification and validation activities
- Responsible for the complete calibration process (including scheduling, internal calibration WI, review of reports, OOT/OOS assessments).
Quality Engineer
Tyco Electronics
06.2010 - 12.2010
- Supplier development and supplier qualification.
- Develop check sheets and part quality plans for enhanced supplier management
- Implement FMEA to regulate supplier processes.
- Verified and endorsed corrective actions from suppliers.
- Scheduled internal audits at regular intervals.
- Ensured compliance with ISO 9001 standards during external assessments
- Responsible for Production and Process Controls (Verification and validation activities, PPC changes), Equipment qualifications at site.
- Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency through the CAPA process at the site.
Supplier Quality Engineer
ACS (General Motors)
08.2008 - 06.2010
- Evaluated and endorsed PPAP and Run@Rate forms.
- Conducted training sessions for suppliers on QMS (TS16949) and ISO 9001 standards.
- Implemented PFMEA, control charts, checklist to establish supplier controls.
- Reviewed and approved supplier corrective measures.
- Awareness training to supplier on TS16949, GD&T, Gauge R&R, 7 QC tools.
- Conducted supplier audits to ensure quality standards were maintained.
Quality Mentor
Dharma Exports Sourcing Pvt Ltd
08.2004 - 09.2005
- Supplier development and supplier qualification
- Establish supplier part quality plan and Supplier Audits.
- Monitoring of supplier process and introduction of SPC, 7 QC tools, and GR&R at the supplier's place.
- Conducting monthly, once Quality review meeting at plant level.
- Conducting internal audit as per ISO 9001:2008 and driving for action implementation.
- Scheduling and completion of calibration activities within the due date.
- As a part of the continuous improvement project team, Kaizens were implemented to reduce rejections.
- Analysis of customer complaints and generating report for customer complaint parts through 8D process.
- Conducting Process Audit and driving for action implementation.
- Conducting daily meetings with cross-functional team and working for turnbacks and improvements.
- Developed a comprehensive mentoring program to support new employees in their transition into the company.
- Monitored and evaluated mentees' progress, providing feedback and guidance to ensure success.
- Mentored individuals on professional development topics such as communication skills, problem-solving and goal setting.
Quality Inspector (Apprenticeship)
Delphi Automotive systems Pvt Ltd
07.2003 - 07.2004
- Reviewed and inspected products for conformance to established standards, specifications and customer requirements.
- Performed visual inspections of components for surface defects such as scratches, dents, burrs.
- Conducted dimensional checks with various measuring instruments, including micrometers, calipers, gauges, CMM, height gauge, profile projectors, etc.
- In-process audits, incoming and in-process inspection, supplier audits.
- Implementation of check sheet and control charts at the supplier to monitor and reduce defects.
- Fixing day-to-day shop floor issues.
- Calibration activities, Distortion study, and Patrol inspection, Layout inspection for components.
- GR&R study, Training, and Monitoring of inspectors
Education
Bachelor of Engineering - Mechanical
Dr Ambedkar Institute of Technology
Bangalore, India06.2008
Diploma in Mechanical Engineering - Mechanical
K. S. Polytechnic
Bengalore, India09-2003
Skills
- Medical Devices Manufacturing
- Quality Audits
- QMS Standards
- Product Quality Trending
- Corrective and Preventive Actions
- Calibration
- Purchase Controls
- New product introductions
- Production Transfers
- Team motivation
- Team handling
- IQC operations
- FQC operations
- Risk Management
- Technical standards (IEC 60601, IEC 62304, ISO 10993, ISO 15223)
- AERB
- Lean Six Sigma Green Belt (Black Belt Training completed)
- US FDA, EU MDR, IMDR, ANVISA, TGA, Health Canada, MHLW, etc
- Automobile manufacturing
- Good Manufacturing Practices
- Lean Six Sigma techniques
- 7 QC tools
- Project Management
- Supplier Management
- Equipment qualifications
- Mastery of quality processes
- Problem-solving abilities
- Document Management
- Internal Auditing
- Operation Monitoring
- Continuous Improvement
- Supplier Relationship Management
- Compliance Monitoring
- Team Training
- First-Article Inspection
- External audit support
- Operational Improvements
- Customer Satisfaction
- Document Control
- Total Quality Management
- Quality processes
- Validation management
- Performance monitoring
- SOP Development
- Statistical process control
- Supplier quality management
- Customer complaint handling
- Change Control Management
- Validation Protocols
- Operational Excellence
- Documentation Control
- Quality system review
- Quality Management Systems
- Process Validation
Accomplishments
- State 6th rank in Diploma.
- Zero NCs from FDA inspection and other external Audits.
- Successful execution of NPI and Implementation of QMS changes.
- Variable cost productivity projects and process improvement projects.
- CE certification for MDR regulation within 6 months.
- NABL 17025 certification within 6 months.
- NPI launch within 12 months for Market with IMDR certification.
- Product registration for USFDA regulation within 18 months
- Regulatory Strategy and Product Registration for International Market
Personal Information
- Date of Birth: 11/14/84
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Affiliations
- Participates in Marathon
- love doing trekking, playing chess and cricket with friends, colleagues and family.
Certification
- Foundation of GE leadership course,Change Acceleration process (Crotonville training)
- Presentation skills at GE (Crotonville training)
- Certified Lean Six Sigma Green belt and Qualified for Black belt
- Six Thinking hats training by Edward de Bono.
- CQI and IRCA Certified Medical Devices- QMS Lead Auditor (ISO13485)
Languages
Telugu
First Language
English
Proficient (C2)
C2
kannada
Advanced (C1)
C1
Hindi
Intermediate (B1)
B1
Tamil
Intermediate (B1)
B1
Disclaimar
I solemnly hereby declare that the above information provided in this resume is true to the best of my knowledge and belief.All information in this resume is right and truthful.
Timeline
Head of Quality Assurance and Regulatory Department
Innovation Imaging Technology Private Limited
01.2022 - Current
Senior Quality Assurance Leader
Wipro GE Healthcare Pvt Ltd
12.2010 - 01.2022
Quality Engineer
Tyco Electronics
06.2010 - 12.2010
Supplier Quality Engineer
ACS (General Motors)
08.2008 - 06.2010
Quality Mentor
Dharma Exports Sourcing Pvt Ltd
08.2004 - 09.2005
Quality Inspector (Apprenticeship)
Delphi Automotive systems Pvt Ltd
07.2003 - 07.2004
- Foundation of GE leadership course,Change Acceleration process (Crotonville training)
- Presentation skills at GE (Crotonville training)
- Certified Lean Six Sigma Green belt and Qualified for Black belt
- Six Thinking hats training by Edward de Bono.
- CQI and IRCA Certified Medical Devices- QMS Lead Auditor (ISO13485)
Bachelor of Engineering - Mechanical
Dr Ambedkar Institute of Technology
Diploma in Mechanical Engineering - Mechanical
K. S. Polytechnic
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