Chen Qiuni

Sensior Quality Assurance at 3DMedicines
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Contact Information
Location
Singapore, SG
Languages
  • English -
  • Chinese -
  • Japanese(Basic) -

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Lee Kuok En, Ralph

I worked with Qiuni directly during her internship with us from March - May 2013 (3 months). Her role involves assisting the Human Resources department in developing an on-job-training curriculum for the hydraulics assembly and testing of marine deck machinery. Some of her responsibilities include drafting out work instructions, identifying performance standards, indexing of hydraulics-related resources, and crafting of lecture notes and assessment checklists. She is highly driven, and does not shy away from hard work. Oftentimes, she is at the shopfloor observing and communicating with blue-collared workers to further understand their roles better. At times, she even gets her hands dirty by getting involved in the process through the manual assembly of some hydraulic components. She also expresses confidence in her work, and has shared her experiences and knowledge during a meeting with various directors and senior managers of the Company. Qiuni is also highly participative in the Company’s weekly work-life balance initiatives outside of work. Her colleagues have also provided positive feedback on her disposition, and her ability to interact with them at comfortable level. In closing, Qiuni has contributed much to the Company during her tenure with us. Because of this, the Company has now achieved the certified on-the-job training centre accreditation from the Institute of Technical Education (ITE), Singapore. It has been my honor and pleasure to have been able to work together with Qiuni.

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Credentials

  • Internal Auditor内审员(China)
    华光认证
    Nov, 2019
    - Sep, 2024
  • JLPT5
    -

Experience

    • Biotechnology Research
    • 1 - 100 Employee
    • Sensior Quality Assurance
      • Apr 2020 - Present

      Design Quality Mangement for new instrument Design Quality Mangement for new instrument

    • Singapore
    • Biotechnology Research
    • 1 - 100 Employee
    • Quality Engineer
      • May 2019 - Mar 2020

      • Keep monitoring and close CAPAs and implement the process SOP with different departments improve the efficiency of the company. • Successfully conducted internal audit, external audit, mock recall and management review to ensure compliance to the QMS. • Successful trained people and maintained of the QMS and ISO13485 for medical devices. • Successfully handling complaints about the quality problems and supervising the implementation of solutions and preventing recurrence of non-conforming products / services for the company. • Successfully communicate with suppliers and implement corrective measures (SCAR) to reduce unnecessary losses for the company. • Successfully conducted annual management reviews, and successfully improved the company's efficiency by 10% (shorten the completion time) by adjusting the company's quality goals. • Successfully optimizing the operation process and the handover process between departments, which improved the company's efficiency by 10% (shortened completion time / project). • Provided technical guidance and direction on risk management with to ensure compliance to the quality system regulation and ISO standards Show less

    • Singapore
    • Medical Device
    • 1 - 100 Employee
    • Quality Engineer
      • May 2017 - Aug 2019

      • Collaborated with Project Management to optimize Design Control processes and developed Sustaining Quality Engineering processes. • Collaborated with R&D team to implement verification and validation process during design phase. • Supported Risk Management activities according to ISO14971 and ensured compliance to standards and regulations. • Successfully implemented incoming quality inspection (ICQ) and in-process quality inspection (IPQC) and outgoing quality inspection (OCQ). • Supported identified possible root cause and solution with different teams and hands on the troubleshooting in system level during DVT and EVT phase, especially the EMC test. • Monitored and tested product performance, and work with developers to implement those issues found. • Successfully conducted internal audit annually and supported external audit and close CAPAs to ensure the audit findings been solved. • Closely worked with BD team (Business Development) to support R&D team with design specifications. PROJECT Histoindex Show less

    • Quality Engineer
      • May 2016 - May 2017

      • Provided technical guidance and direction to ensure compliance to the quality system regulation and ISO standards • Assisted in the training and maintained of the QMS and ISO13485 for medical devices • Assisted and prepared documents with CFDA registration including EMC test, safety test and clinical trial protocol. • Prepared and co-ordinated both internal/external audits and changed approvals together with the regulatory affairs team • Successfully implemented CFDA with Innovative Application (National level & Province level). • Successfully set and documented Quality Management System with teams according to ISO13485 (YY/ T0287) for CFDA. Show less

    • Singapore
    • Primary and Secondary Education
    • 1 - 100 Employee
    • Intern-Marketing Assistant & Teaching Assistant
      • May 2015 - Jul 2015

      - Supports marketing operations by compiling, formatting, and reporting information and materials. - Supports teachers presentations by assembling quotations, proposals, videos, slide shows, demonstration and product capability booklets; compiling account and competitor analyses. - Prepares mailers and brochures by formatting content and graphics; arranging printing and internet packages. - Supports recruiting students - Supports marketing operations by compiling, formatting, and reporting information and materials. - Supports teachers presentations by assembling quotations, proposals, videos, slide shows, demonstration and product capability booklets; compiling account and competitor analyses. - Prepares mailers and brochures by formatting content and graphics; arranging printing and internet packages. - Supports recruiting students

    • Intern -Assistant Engineer
      • May 2014 - Aug 2014

      Exposing the various containers handling equipment in the Port as well as the different kinds of cranes. Implementing RFID technology to recognize prime-mover (container truck) operating in the Port. Setting up a RFID reading and programming station and assist in the testing of this system. Exposing the various containers handling equipment in the Port as well as the different kinds of cranes. Implementing RFID technology to recognize prime-mover (container truck) operating in the Port. Setting up a RFID reading and programming station and assist in the testing of this system.

Education

  • National University of Singapore
    Master's degree, Industry &system engineering
    2017 - 2020
  • National University of Singapore
    Bachelor's Degree, Electrical Engineering
    2013 - 2016

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