Vinay Ram Venkatesh Babu
Biomedical Engineer
Castlebar, Mayo
Summary
- Detail-oriented Biomedical engineer with extensive experience working in a high production fully automated class III medical device manufacturing facility.
- Skilled and conscientious optimiser of the production environment, focusing on quality, health and safety and business continuity.
- Demonstrated a primary commitment to patient safety and product quality.
- Excellent communication skills, written and verbal, with a good working knowledge on QMS systems such as Adaptiv, Windchill and QMS standards such as ISO 13485:2016, ISO 14971, 21 CFR Part 820.
Overview
6
6
years of professional experience
1
1
year of post-secondary education
3
3
Certifications
Work History
Quality Operations Technician
Johnson & Johnson - DePuy Synthes
09.2021 - 11.2022
- Proficient in making decisions related to product quality, visual inspection of parts against the defined acceptance criteria, review batch paperwork and disposition of non-conforming product.
- NR and CAPA activities - Using root cause analysis, lean principles & 6 sigma tools to investigate and ensure closure of NCs as per SOP achieving a 100% completion rate. Create and Implement awareness trainings for quality alerts, NR and CAPA for production.
- Working with a cross-functional team ensuring highest product quality is achieved through robust quality system processes. and compliance with GMP, NCR and CAPA and other cGxP activities.
- First point of contact for any product related issues on the line. Provided effective and responsive QA support to Operations to resolve in-house, customer and supplier issues.
- Experience in continuous improvement projects -Implementation of de-ionized water in the IPC line to assess and monitor staining , data gathering to assess success rate of the implementation and certification of production team. Results - 90% reduction in the defect.
- Risk management activities - Ownership of documentation walks, review of maintenance schedules (QRACs, ECCs) and GDP error monitoring.
- Monitor manufacturing of assigned products, assuring compliance with DHR while resolving deviations and assuring complete and correct Device History Records are maintained.
- Supported validation activities within value streams including co-ordination of engineering trials on production assets, quality review of documents (TSRs).
- Ensuring strict adherence to company policies, cosmetic standards, quality procedures and promoting a quality culture within the business unit. Scrap rate reduction in the value stream - 80.4% to 11.5 % in 15 months.
- Ensure that all relevant Quality KPI Data is recorded, reported and actioned in an efficient manner. Represented Quality in weekly meetings to address GMP and safety trends within the value stream.
- Applied critical thinking to break down problems, evaluate solutions and make decisions i.e. Core team member (QA) for troubleshooting product defects. Liaising with cross functional team to facilitate trials and root cause defect. Results - Scrap reduction from 7.9% -0.9%.
Quality Technician
Multi Color Corporation
10.2023 - 03.2024
- Worked in conjunction with Operations, planning and warehouse team to streamline the product release via QC control process in a timely manner. Results - 96% OTIF rates achieved.
- Carrying out and recording in-process inspections throughout the site and taking mitigatory actions based on recurring trends.
- Quality Inspection, documentation and preparation of samples for customers and disposition of non-conforming product.
- Control and release of non-conforming products and escalation of Quality issues to the Quality engineer and Quality manager if necessary.
Intern
Skanda Machine Tools Private Limited
01.2018 - 03.2018
- Analyzed problems and worked with teams to develop solutions.
- Worked as a proactive member of a team and assisted the engineers during assembly of spindle, fixtures associated with CNC machines.
- Analyzed various machining processes and monitored safety parameters associated with primary components of a CNC machine by communicating actively with fellow workers during the course of training.
- Communicated effectively with faculty and staff and accepted critiques and suggestions for areas of improvement.
Education
Master of Science - Biomedical Engineering
National University of Ireland Galway
Ireland 09.2018 - 10.2019
Bachelor of Technology - Mechanical Engineering
Jain University
Bangalore, India 08.2014 - 2018.05
Certification
Lean Yellow Belt Certification
Timeline
Quality Technician
Multi Color Corporation
10.2023 - 03.2024
Quality Operations Technician
Johnson & Johnson - DePuy Synthes
09.2021 - 11.2022
CQI and IRCA certified ISO 13485:2016 Lead Auditor course training. - Online Course
05-2021
Master of Science - Biomedical Engineering
National University of Ireland Galway
09.2018 - 10.2019
Intern
Skanda Machine Tools Private Limited
01.2018 - 03.2018
Bachelor of Technology - Mechanical Engineering
Jain University
08.2014 - 2018.05
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