苏州招聘

职位描述：
工作职责
1. Manage the quality team and oversee the daily work, assess and promote the KPI of quality supervisor, engineers, and inspectors.
2. Establish, maintain and improve SunMed AP’s quality management system complying with ISO13485, FDA 21CFR 820 QSR and other regulatory and statutory requirements
3. Surveille the SunMed AP’s overall quality through the quality data collection and analysis, quality objectives setting and following up, preside over the weekly/monthly quality meeting for improvement to meet the objectives.
4. Provide the support for process quality planning and control, review and approve the quality control plan, instructions and inspection standard, drive related people to improve the process quality.
5. Assist to analyze the root cause and provide professional corrective actions for significant quality problems in production.
6. Outgoing product shipment release approval.
7. Participate in the QFD for new project quality and quality planning, provide the support to quality engineers.
8. Supplier quality control and management, assist the quality engineer and IQC to improve the key suppliers’ quality.
9. Participate in the process validation and re-validation, check the process validation protocol and report, approve the quality inspection /testing report, Cpk analysis report for validation
10. Nonconforming products review for the critical nonconformities, concession, deviation or scrap’s final approval
11. Lead the customer complaints investigation, improvement and CAPA response
12. Lead or organize the continuous quality improvement projects.
13. Conduct the internal audit and management review as the leader and management representative, coordinate with external quality audit as the interface.
14. Measure tools calibration and management, document control, procedures and quality reports approval.
15. NCR, CAPA, SCAR closure approval and ECR/ECO and DHR package approval.
16. Quality awareness, culture , procedures, and regulatory training for related people
17. Quality team building and development, quality tools and skills training for quality team.
18. Other tasks assigned by superior

任职要求：
1. Bachelor’s in related field.
2. Ability to read, write and speak in English.
3. At least 5 years’ experience in the medical device industry would be preferred.
4. Knowledge of FDA regulations, ISO 13485 and other national and international regulations and standards
5. Preferably injection molding and ultrasonic weld experience.
6. Experience with applying statistical methods for analyzing data.
7. Experience with common computer applications/programs such as Microsoft Word, Excel and PowerPoint.
8. Excellent organizational, communication and interpersonal skills with a high degree of attention to detail.
9. Ability to work effectively in a team environment and communicate with team members and customers at all levels of the organization. 举报 分享

Talentview泰能人力