珠海招聘

职位描述：
Major Responsibilities:
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.

Requirements & Qualification:
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

珠海顺美医疗器械有限公司（SunMed AP,Ltd）是美国顺美医疗集团（***************）在亚太地区的核心工厂和运营中心。美国顺美医疗集团总部设在密西根州大溪城，旗下有多家知名医疗器械企业如Ventlab、Ethox、Bay Medical等等。

珠海顺美医疗器械有限公司位于珠海市斗门区，生产面积近两万平米，拥有员工约550人。生产的品牌包括Ventlab、BreathTech、BreathRite及Stat-Check等。产品在世界呼吸、麻醉和急救领域享有广泛的知名度。其婴儿急救产品在美国儿科和心脏学会出版的《新生儿复苏教程》（Neonatal Resuscitation)作为代表医疗器械使用。

公司重视客户群体，同时也珍视每一位员工。公司秉承公正、公平的态度，***程度地调配资源，为员工提供良好的职业发展机会，力求为员工提供完善的福利以及良好的成长环境。

热忱欢迎您的加入！

一、福利待遇：
 公司提供具同行竞争力的薪资待遇。
 公司实行五天八小时工作制。加班严格按照劳动法律法规计算加班费（平时加班1.5倍、休息日加班2倍、法定节假日3倍）。
 入职当月即购买社保。
 购买住房公积金。
 入职即享受国家法定节假日、婚假、产假、丧假、工伤假等带薪假。
 入职满一年后可享受带薪年假。
 公司提供免费的营养餐，伙食质量优良。
 每月为生日员工发放生日福利。
 员工享受结婚贺礼金、生育贺礼金、丧事慰问金等福利。
 每年公司根据业绩提供奖金及调薪机会。
 不定期组织员工进行户外文体活动，公司设有篮球场、足球场、乒乓球桌、台上足球等配套设施，丰富业余活动。
 为员工提供多渠道的培训学习机会。

二、乘车方式 ：
从市区方向出发：乘坐公交车到“湖心路口总站”，转530到“超群电子”站下车，过对面马路即到。
从井岸方向出发：乘坐502、405 到“超群电子”站下车，过对面马路即到。
从平沙、南水方向出发：乘坐502、405、530到“超群电子”站下车即到。

三、联系方式：
公司地址：广东省珠海市斗门区乾务镇乾南工业区珠峰路南新河段6－9号（超群电子旁）
联系人：赵小姐
应聘邮箱：sally@sun-medap.com
联系电话：0756-5586997
传真：0756-5586998

如需了解公司的更多信息，请访问以下网站：
***************

(本公司仅在前程无忧网、珠海人力资源网有发布招聘信息！）