Profile
• Green Belt holder in Six Sigma (Trained & Certified by INDIAN STATICAL INSTITUTE – Bangalore)
• Leading and Managing a team of Engineers and Technicians to ensure process and product quality for Medical & Industrial products.
• Responsible for ensuring the DHR (Device History Record) & DMR (Device Master Record) is maintained and updated for each Medical product.
• Monitoring and Measuring the quality performance of the organization, i.e. Customer complaints, RMA, etc. against the set targets.
• Strong Quality process acumen. Able to quickly identify problem areas & successfully implement solutions.
• Familiar with the DMAIC, Core tools, DOE’s (Simulation), FMEA, MSA, APQP & PPAP.
• Qualifying the New product in SMT, Wave (IPC 610, 600, J-std 020 & 001) conformal coating (IPC-HDBK 830 & TM 650) & backend assembly process.
• Develop manufacturing documentation for assembly.
• Validating and implement complex system level Bill of Material.
• Qualified existing product to reduce the rejection rate in SMT, back end assemblies by identifying the process variation and placing improvement action through change in process or making poke yoke fixture to enhance customer satisfaction.
• Analyze customer issues, develop necessary actions and ensure optimal levels of customer satisfaction to provide appropriate.
• Ensure Quality Management System processes are “established, implemented and maintained”.
• Report to “top management” on the QMS performance and where improvements are needed.
• Ensure that everyone in the organization is aware of customer requirements.
• Internal Auditor - ISO 9001:2008, (Knowledge on ISO 13485 (Medical STD), 14001 & TS16949).
• Preparing internal audit schedule (IQA).
• Manage internal Quality System audit, Process audit to meet customer specific requirement in product launching effectively and efficiently.
• Coordinating for the customer audits & reviews.
• Handling product related regulatory audit and implement the requirement in assembly.
• Exposure & capability to handle Reliability and Failure Analysis tests.
• Exceptional relationship and communication skills, Adapt to work with teams across functions.
• Training provided to new employees on quality and Customer requirement, validation through Kappa Study.
• Created process to improve readiness and ownership of incoming sample material.
• Improving the supplier process by QPR review and auditing local supplier for process and product development.
• Managing supplier’s corrective & preventative actions, also working on improvement of process.