Job Description
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.
Key Deliverables(the main deliverables expected in the first 18-24 months)
- Regular reports: daily/weekly/monthly reports.
- Internal and external quality determination standards, including remake, customer satisfaction assurance, compensation, etc.
- Data analysis: Root cause and impact analysis.
- PDCA/CAPA quality improvement planning, execution, tracking, and verification.
- Collaborate with responsible departments for the management process of SOP formulation, revision, issuance and termination.
- Regular reports and ad-hoc investigations requested by APAC/GQA.
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
Mobility
Willingness to travel occasionally (domestically).
