- Hygiene, Audit, CAPA, QAC
- Conduct routine QA monitoring and audit activities covering fiber production processes, equipment, raw material handling, packaging, storage, delivery conditions, and building facilities to ensure compliance with quality and hygiene standards
- Monitor hygiene compliance in Fiber production lines, ensuring no contamination risk (dust, debris, oil mist, moisture, metal particles, foreign matter).
- Perform Quality Assurance Capability (QAC) inspections and prepare reports for internal audits and customer-required audits.
- Lead/assist in nonconformity investigation, root cause analysis (RCA/5Why/8D), and implement CAPA for Customer Complaints, Quality Incidents, and process deviations.
- Work cross‑functionally with Production, Maintenance, E&I, CTS, and Engineering teams to improve product quality, eliminate root causes, and prevent recurrence of issues.
- Product Safety & Regulatory Compliance
SDS, Regulations, Customer Safety Requirements
- Prepare, review, and maintain SDS, Product Safety Statements, Compliance Certificates.
- Ensure product compliance with global regulations:
- REACH
- RoHS
- TSCA
- California Proposition 65
- FDA 21 CFR (Food Contact)
- EU 10/2011 – EU Positive List
- Japan Positive List (JP PL)
- Support customer audits/questionnaire related to chemical safety and regulatory compliance.
- Prepare safety declarations and respond to customer technical inquiries regarding chemical composition, restricted substances, and regulatory standards.
- Fiber Hygiene & Contamination Control
- Develop & execute Hygiene Audit Plans for Fiber production areas.
- Identify contamination risks across the lines and implement actions to maintain clean production environments.
- Conduct foreign matter analysis using FTIR and issue contamination investigation reports.
- Monitor critical hygiene parameters (dust level, fiber debris control, humidity, machine cleanliness).
- Provide Hygiene Training for employees, subcontractors, and external personnel entering Hygiene-controlled areas.
- Ensure adherence to hygiene SOPs, zoning rules, protective equipment usage, and contamination-prevention practices.