Experience

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  Bbraun

  Apr 2007 - Apr 2010

  1. To lead and manage the organization and management to ensure the success and on-time delivery of process improvement projects.2. To identifying proactive measures for further potential and drive a continuous improvement in all aspects in the assigned projects.3. To executing, implementing and coordinating all activities with regards to the assigned projects and ensuring the success of projects are as per schedule, investment cost, quality as requested by the internal customers.4. To manage and minimize deviations and risk of assigned projects and follow-up investment appraisal for project approval progresses as well as providing regular project status updates to the superior and management.5. To communicate with other plant counterpart (Vietnam, Germany) to allign/share projects, improvement and issue related to quality of products.6. Implements plan for introduction of new or expanding products, materials processes, equipment, tooling or machinery into production and ensure proper documentation.7. Responsible for leading the implementation OEE (Overall Equipment Efficiency) in Medical plant. Show less 1. To take proactive measures in order to identify gaps and deviations as soon as possible and to take appropriate corrective actions immediately.2. Analyze problem immediately, identify the root causes and initiate suitable corrective actions to avoid any reoccurrence.3. To identify proactively further potential and drive a continuous improvement in all aspects.4. To ensure that all operations in my area of responsibility are compliance to these regulations (GMP, FDA, ISO 9001 & ISO 13485).6. Communicate with suppliers on product specification and components evaluation.7. Demonstrate method and train workers in sequence of processing and operation (process and equipment specifications) especially in new product development.8. Recommend measures to improve production methods, equipment performance and quality of product.9. Production yield, productivity and participating in process and product validation. Continuous process yield improvement. Show less

  • Project Engineer

    Feb 2008 - Apr 2010

  • Process Engineer

    Apr 2007 - Feb 2008
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  St. jude medical

  Apr 2010 - Mar 2014

  1. To conduct supplier audit and perform periodic audits of Supplier Quality Systems for the purpose of assuring continued Supplier conformance to the quality system requirements.2. To access the qualification of supplier and manage the supplier assessment system to ensure compliance with all regulatory and industry standards (GMP, FDA, ISO 9001 & ISO 13485).3. Investigate and resolve supplier quality issues and implement supplier improvement programs.4. To manage Receiving inspection team, plan and execute incoming quality inspection activities. Also, SME (Subject Matter Expert) for Receiving Inspection. To handle internal, external audits (FDA, TGA, CCC and TUV) to ensure compliance of department.5. To ensure that incoming parts quality meets quality standard set / required and responsible for incoming activities which including incoming material acceptance and maintenance of components part number.6. To maintain and update, when necessary all incoming procedure and compliance to procedure requirement.7. To represent Super user for Quality management (QM) and handle SAP project which including to ensure user has been trained and certified to use SAP in Receiving Inspection and Supplier Quality.8. To ensure no production line down caused of part released delayed.9. To support and drive major quality improvement and cost saving projects across functions for plant wide.10. To identify proactively further potential and drive a continuous improvement in all aspects to supplier.11. Initiate and follow-up Supplier Corrective Actions (SCAR) in partnership with Manufacturing Engineering to ensure complete and effective root cause analysis and corrective action implementation.12. To handle Nonconformance issue until resolved. Updating outgoing reject rate and quality related reports for monthly reporting. Show less 1. To validates and evaluates data, analyzes cause of failures, suggests remedies and writes up results.2. Define test cases and creates validation documentation (IQ, OQ, PQ) and procedures for conducting tests.3. Participate and contribute to Divisional activities related to the CAPA/NCR process. (Management Review, NCRB, NCR summits etc).4. Lead/coordinate preparation, participate and follow up to Internal, Corporate and third-party compliance audits.5. Implements test procedures, collects data and analyzes test results by visual and statistical means.6. Conducts analysis of problems related to documentation and/or testing and initiates corrective actions.7. Resolves and/or facilitates the resolution of problems including identifying causes to prevent re-occurrence.8. Identify and analyses of quality issues with appropriate corrective action and timely resolution.9. Ensures that Qualifications Tests are conducted according to plan, that failures are analyzed, and corrective actions are suggested and implemented.10. Working closely with US/Sweden counterpart in order to fulfill regulatory agencies standards and requirements and within specified parameters.11. Interfaces with various production, engineering and quality personnel for validation, verification and coordination purposes related to technology transfer and development.12. Provides technical guidance and support to other engineers and/or technicians, mentor less experienced engineers.13. Interacts with various vendors relating to delivery, installation, test and validation. Show less

  • Senior Supplier Quality Engineer

    Nov 2012 - Mar 2014

  • Quality Engineer

    Apr 2010 - Nov 2012
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  Robert bosch tool corporation

  Apr 2014 - Feb 2018

  Staff quality engineer

  1. Responsible for qualification testing, quality management, reliability testing, problem resolution, quality inspection plan, component first article inspection approval (ISIR) and customer complaints (PSS).2. Develop, review and monitor the effectiveness of quality control procedures and process, propose and implement improvements where necessary.3. Drive and integrate data analysis activities and projects like warranty data analysis reporting from SAP system (BIQIC), feedback on customer complaints, 8D report analysis and FMEA.4. Led for process improvement projects and update management board on the improvement results.5. Actively involve, self-organize and contribute to delivering quality product along Product Development Management (New Project) in agile mode. Show less

• 

  Hp

  Mar 2018 - Oct 2023

  1. Engage R&D and Product Development to enable New Product Introductions and Extensions.2. Engage and drive solutions across HP value chains team such as Process Engineering, Supply Chain and Production, Tech Support, to improve Manufacturing line productivity, Yield and Quality.3. Manage Marley P production ramp in support of the TIJ4X Gen1 platform as part of IPS Ink in the Office priority.4. Design, manage and improve Marley P factory performance for quality, yield and throughput with implement strong process control and quality system.5. Continuously identify, innovate and develop long term engineering solutions to alleviate manufacturing bottlenecks, deliver operational excellence, optimize business costs and objectives.6. Lead and drive investigations into operational, tooling, process and product quality issues to resolution with effective corrective and preventive actions.7. Work closely with the Process Engineering and cross functional team (SIE, CA, SQE etc) to review and improve product quality.8. Leads and support multiple Qualification (ReMIT, MIQ, Host Retune, Columba ink, Eco Neptum Ink, Mazama SHF, Seal, PCA etc) with teams of manufacturing engineers, AMTC, SIE, CA. Show less

  • Product Engineering Manager

    Feb 2022 - Oct 2023

  • Product Reliability Technical Lead

    Apr 2021 - Feb 2022

  • Specialist Product Engineer

    Mar 2018 - Mar 2021
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  Dexcom

  Oct 2023 - now

  Qa engineering manager

  - Working closely with Manufacturing and Engineering function for Planning, Implementing and managing compliance of manufacturing processes with quality, and regulatory requirement as well as driving, develop, define implementation technical quality assurance and control systems and activities.- Driving a culture of continuous improvement by employing Process Improvement concepts and managing metrics, escalations, reporting, and communicating internally and externally.- Active core team member of sustaining management teams, supporting complex, cross-functional quality issues in a variety of subject matter areas, and driving resolution and proactive solutions to customer complaints. Show less