Quality Engineering Manager

As a Quality Engineering Manager, where you'll lead and/or coordinate the critical quality initiatives including product market release, investigations, trend analysis, product hold, field corrective actions, supplier audit, supplier quality management and continuous improvement.

• Product market release-responsible for medical device market release. Review the DHR from medical device supplier and approve or reject the medical device market release for each lot.
• Participate supplier audits and regulatory/compliance agency audits. - coordinates regulatory inspections (NMPA audit to supplier), drive the supplier to respond to audit findings till closure; carries out supplier on-site audit, audit findings tracking, drive the corrections by supplier till closure.
• Supplier quality management – work with cross-functional team on medical device supplier evaluation, supplier changes, NC and CAPA approvals.
• Responsible for review the DMR released by Cook China Medical.
• Support the design transfer from Cook China Medical to supplier.
• As key member of CCB, plan, review, and/or approve change requests.
• Create 1~2 years strategic plans for quality engineering teams.
• Lead and drive investigation processes- maintain the monitoring system, lead the cross-functional team of Cook Medical as well as drive the supplier to conduct root cause analyses, determine product impact, corrective action activities for identified quality issues and ensure timely handling the investigation and conclusion in compliance with NMPA, ISO 13485 and Cook cooperate requirements.
• Perform and analyses quality trends and signal detection - Collect, analyse, and interpret quality data using statistical tools to identify trends, signals, and areas of poor performance. Prepare and present reports on quality trends and findings to management and cross-functional teams.
• Support Six Sigma and continuous improvement projects by providing data-driven insights
• Implement and monitor key performance indicators (KPIs) related to quality.
• Conduct risk-based decision making and effective resolution of issues.
• Provides oversight for quality programs and systems – develops, maintains and improves quality management systems, processes, and procedures, ensuring compliance with Cook Cooperate requirements and external standards (NMPA GMP, ISO 13485).
• Prepares quality documentation and reports - authors or reviewer of CAPAs (Corrective and Preventive Actions), investigation reports, quality metrics summaries and regulatory reports or submissions for internal and external stakeholders.
• Other tasks assigned by the supervisor.

• Bachelor's degree or higher in a relevant major including medical devices, biomedical engineering, mechanical engineering, electronics and bioengineering
• Minimum of 8 years of quality engineering experience in medical device area with 3+ years of managerial experience.
• Familiar with medical device regulations: NMPA GMP, ISO 13485
• Experience leading internal and external audits (NMPA GMP, ISO 13485)
• Familiarity with Six Sigma principles; Six Sigma Green Belt or higher certification preferred.
• Fluent English both in writing and oral