Quality Assurance Specialist

2 days ago

Hukou Township Hsinchu County Taiwan HOYA Group Full time NT$60,000 - NT$120,000 per year
Description
The Stakeholders

The following are the key stakeholders for this position:

  • Global QA 
  • Customer service team
  • Cut & Edge team
  • Sales/Marketing
Responsibilities
Major Responsibilities 

1. Regular quality control affairs:

  • Customer returned ST lens justification (sellable or not).
  • Customer RX returned lens justification (remake or not).
  • Internal defect justification (lens/frame damage).
  • Inbound inspection, for the special case to perform sampling or 100% check.

2. Customers complain management:

  • Collect, sort and analyze the customer complain cases.
  • Root cause finding & action owner identification.
  • Follow up improvement progress.

3. Quality standard & process standardization; to build/maintain the following:

  • Inspection standard.
  • Inspection instrument calibration planning and execution.
  • Product quality issue communication flow with suppliers (mainly HOLT).
  • Management of CAPA.
  • Establish the Quality Management System (QMS) including SOPs issuing and revision.

4. Reporting: (daily, weekly, monthly)

  • Product defect report.
  • C&M yield report. 
  • Customers complain & action progress reports.
  • Regular/specific report requested by APAC/GQA.

5. Others shared jobs:

  • Operational support such as C&M outsourcing, defect lens registration and destruction.
  • Periodic reporting requested by regulation or industrial park.
Qualifications
Qualifications
  • Education: College degree, preferably in Optometry.
  • Experience: 
  • 5+ years' experience in medical device/pharma industry for quality assurance.
  • Keeps up-to-date knowledge and flexibility with medical devices, optical product, demonstrated ability to drive results.
  • Knowledge and Hard Skills:
  • Good communication, interpersonal, and consultative skills.
  • Keeps up-to-date knowledge and flexibility with solid execution, demonstrated ability to drive results.
  • English ability to read, write and understand.
  • Computer skills (Excel major)
  • Behavioral Attributes: 
  • Initiative, proactiveness, and independence
  • Willingness to take challenge
  • Achieving Results 

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