Senior Quality Engineer

Mô tả Công việc
Lead and oversee quality assurance initiatives to ensure the company's products meet established quality standards and continuously improve performance. Drive continuous improvement across production processes and product quality by leading technical teams and implementing advanced QA methodologies. Develop and execute comprehensive quality strategies, manage customer quality performance, and mentor Quality Engineers. Collaborate with cross-functional departments to establish quality culture and ensure regulatory compliance. Establish, implement, monitor, and continuously improve the Failure Mode and Effects Analysis (FMEA) process to ensure early identification and mitigation of risks related to design, raw materials, manufacturing processes, and Critical Control Points prior to releasing new items for mass production.
ESSENTIAL DUTIES & RESPONSIBILITIES
Lead and mentor a team of Quality Engineers. Provide technical guidance, conduct performance reviews, and support professional development and training programs on QA best practices and quality standards.
Review and approve quality inspection plans, procedures, checklists, and SOPs developed by Quality Engineers. Ensure compliance with company standards and regulatory requirements.
Oversee quality analysis of new products and processes. Conduct advanced failure mode analysis and recommend preventive measures to eliminate quality risks before production.
Monitor quality test results and data trends. Ensure data accuracy and integrity. Provide analysis and strategic insights to Quality Engineers and management on quality performance and areas of concern.
Lead process improvement initiatives in partnership with Quality Engineers and cross-functional teams. Identify root causes, develop solutions, and oversee implementation of corrective and preventive actions (CAPA).
Oversee the customer complaint management system. Review complaint analysis and action plans developed by the team. Ensure timely resolution and communicate outcomes to management and customers.
Establish and maintain quality metrics, KPIs, and performance dashboards. Monitor quality performance against targets and report results to management. Identify trends and recommend strategic improvements.
Develop and standardize the Failure Mode and Effects Analysis (FMEA) process and integrate it into the New Product Introduction (New GO) workflow, from initial information intake and Coverfit meetings through PP sample development and Pilot Run trials.
Create, standardize, and maintain the FMEA Checklist to comprehensively evaluate four primary risk categories
Material
Design
Process
Critical Control Points.
10. Lead the FMEA risk analysis for New GO items based on PP samples and the new item list provided by the U.S. team. Organize and facilitate FMEA reviews after the Pilot Run and conduct Kit Auditing prior to submitting for Wanek FO Review.
11. Maintain and continuously update the Master-list of Critical Points, logging identified risks and historical issues into the system. Assign clear corrective action items to designated owners and monitor follow-up completion against deadlines.
12. Record and analyze Pass/Fail/Transit rates by SKU across quarters (Q1, Q2, Q3, Q4) to measure the effectiveness of risk mitigation. Collaborate with the Cross-Functional Team (CFT) to determine product change paths: Confirm Change, Running Change, No Change, or Hold Kits.
13. Support the first production run by participating in root-cause investigations and implementing immediate corrective actions for quality issues arising during the initial factory production run.
14. Work closely with the U.S. Team, Coverfit, Sample Development, Cutting, Sewing, OBQ, QC/QA, and Packaging to ensure end-to-end risk control.
15. On-Time FMEA Completion Rate: Ensure prioritized New GO items and essential quality-monitored items undergoing implementation complete FMEA risk assessment on schedule prior to mass production.
16. Defect & Risk Reduction: Measurable reduction in trial run and mass production defect rates.
17. Corrective Action Compliance Rate: Ensure identified risk items in the FMEA Checklist assigned with follow-up actions are completed on schedule. Master list Accuracy: Maintain an updated critical points Master-list achieving over 95% coverage of actual operational risks.