Dewi Komalasari

Dewi komalasari

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location of Dewi KomalasariBatam, Riau Islands, Indonesia
Followers of Dewi Komalasari860 followers
  • Timeline

  • About me

    Sr. QA Engineer / CQI & IRCA 9001:2015 / IATF 16949 / ISO 13485

  • Education

    • Sma negeri 1 padang

      2008 - 2011
      High school diploma science
    • Institut teknologi nasional (itenas)

      2011 - 2016
      Bachelor of engineering - be environmental engineering bachelor of engineering
  • Experience

    • Pt surveyor indonesia (persero)

      Jun 2013 - Aug 2013
      Intern
    • Badan tenaga nuklir nasional (batan)

      Jun 2014 - Aug 2014
      Research intern

      Worked on a research of “Study of Environmental Radionuclide Effect of Core's Radioactivity of Water, Soil, and Ambient Air at Dominant Windrose Direction”.

    • Japan medical supply

      Jun 2016 - Jun 2019

      Reporting to Production Manager.Guarantees pharmaceutical validation and qualification status prior to mass production release. The main tasks are cunducting, writing and reviewing qualification documentation, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents. Validates monitor, and review operational documents.1. Reviewing/writing validation principles and documents to support verification, FAT, IQ, OQ and PQ activities2. Prepare validation related documents or qualification protocols3. Writing validation standards and protocol templates, such as IQ/OQ/PQ4. Following the FDA requirements (GMPs), ISO 134865 and standard operating procedures (SOPs)5. Comparing results against acceptance criteria, shows deviations and exceptionsBesides validating the processes, Coordinations of the in-depth studies project is initiated to improve the process as the objective of company's startegic cost reduction, environmental friendly, and sustainable manufacturing process. The projects aim to optimise the performance of manufacturing systems in identifying and developing new processes for product manufacture, as well implementing process controls to make sure the products are of a high quality and are manufactured in a reproducible manner. Show less

      • Validation Engineer

        Feb 2017 - Jun 2019
      • Production Engineer

        Jun 2016 - Feb 2017
    • Tdk electronics

      Jun 2019 - Jul 2020
      Production engineer

      Reporting to Production Engineering Director.Represent production during PPAP phases; jig and fixture design and implementation, run@rate determination, control plan, PFMEA and participating for overall 18 PPAP elements, - as well as all product and system requirements are taken into account from the initial product conception to the finished result1) Process Failure Mode Effect Analysis (PFMEA) Moderator2) Project Coordinator of Production Part Approval Process (PPAP)

    • Casco automotive group - an amphenol company

      Jul 2020 - Jun 2024

      Reporting to Quality Plant Manager.Represent Quality Dept end-to-end process; NPI, mass production, customer complaint, and warranty claim.1. Coordinates resolution of customer quality issues through monitoring & improve customer escape to meet the site and customer goal.2. Resolve quality issues, drive quality improvement plans and develop corrective/preventive actions within the company.3. Manage and act on customer complaint (8D) effectively with closed loop feedback mechanism.4. Lead cross-functional team and conduct conference calls with customer and on-site supporting team to resolve customer complaints and develop effective corrective action.5. Engagement in line audit and product verification for internal improvement Host customer quality visit & conduct quality assessment to prep the site for customer audits & visits.6. Monitors customer quality performance and analyze top pareto, trend failures and established improvement plans to help DPPM reduction to management team based on the daily company’s status at customer’s portal.7. Follow up RCCA status, trend analysis and monitor RCCA turnaround time.8. Review RCCA investigations activity and verify effectiveness of the CA implemented.9. Monitoring CAR status, performance & hardware tracking through consistently conference call with external CQE to improve RCCA turnaround time.10. Responsible to work with Production and Engineering for process & quality improvement project.11. Be a part of validation of machine and process prior to mass production release.12. Establish product assembly build instruction for final QA inspection through translates and documents customer requirements as part of inspection plan.13. Handle NPI (PPAP and IMDS) and responsible for First Article Submission/Part Submission Warrant (PSW) and sustaining quality activities within the company.14. Compilation of monthly process capability and statistical process control performance for management review. Show less

      • Sr Customer and Quality Assurance Engineer

        Jan 2022 - Jun 2024
      • Customer and Quality Assurance Engineer

        Jul 2020 - Dec 2021
  • Licenses & Certifications

    • Iatf 16949:2015 internal auditor

      Digisi indonesia
      Jun 2022
    • Ppm reduction plan training & strategic problem solving

      Ford motor company
      May 2022
    • Iso 9001:2015 lead auditor

      Irca | international register of certificated auditors
      Feb 2024
    • Product and process improvement for automotive industry (apqp tools : fmea, spc, msa, ppap)

      Deutsche gesellschaft für qualität (dgq)
      Jan 2020
    • Statistical process control (spc)

      Bsi
      Jan 2019
  • Volunteer Experience

    • Member

      Issued by AIESEC Indonesia on Jan 2012
      AIESEC IndonesiaAssociated with Dewi Komalasari