IdentityExperience in iso 9001:2015, as 9100:2016, iso/iec 27001:2013 process implementation, maintenance and improvement of quality management system
Experience on iso 9001, 13485 standards, audited on process & validation and faced the audits like mdsap, iso and internal audits.
Exposure to internal/external audits and ensuring adherence to process/standard requirements
Experience in preparing new processes, procedures, templates/forms along with
Process owner
Experience in risk management implementation and maintaining risk
Management frameworks
Collection process metrics, analysis, consolidation, reporting with action items
Conduct customer satisfaction survey, review responses, submission of action items for improvement and verify effectiveness of implementation
Experience in using 7qc tools and knowledge of performing rca
Conduct awareness and training sessions for associates on quality management
System
Coordinate with stake holder on matters of concerns and provides recommendations for resolving quality/process related issues
Conduction and facilitation of quality review management system
Implementation of hse process and monthly review and proposing gaps to teams for continual improvement
Lean manufacturing project implementation at ge healthcare (manufacturing) :
- single piece mixed model line for testing and assembly of magnetic resonance high level assembly (mrhla: power supply and amplifier)
- conceptualization and implementation of kaizen s for mrhla modality.
- responsible for periodic kaizen evaluation and walkthrough across site.
- introduction and sustenance of operational mechanism for achieving 5s across site
- implementation of in-house kaizenâ??S for achieving improved cycle time for manufacturing and assembly line for better productivity
Engineering implementation in manufacturing
- supported the implementation of design or engineering changes through ecr/eco.
Engagement and cross functional
- excellent interpersonal skill, collaborated with cross functional teams including quality, manufacturing, process, engineering, sourcing, program for implementation of various projects
Automation: - developed and performed the automation for the test setup for a new product and achieved the cycle time reduction by automation on the existing product.
Customer: - recognized for superior work ethic and high levels of productivity in achieving the site targets for scot
Data trending & analysis: - monitoring product test yield/equipment breakdowns by implementing data trending by using 7qc tools and ensured minimum loss of production due to any adverse conditions & action plan to eliminate the breakdown.
Periodic validation and regular verification of equipment to assure the quality and the preventive maintenance (pm) of the automated test equipment s (ates).
Responsible for transforming engineering test requirements into manufacturing setups.
Hardware and software validation and verification plan (iq, oq and pq) of ates and maintenance of test stations.
Ensure all ates (automatic test equipment) are 100% ehs complaint to mitigate electrical hazard.
Using 7qc tools finding the root cause for the problem and implementing the poke-yoke for the findi
