Job Summary:
The Quality Assurance (QA) Director/Senior Manager will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining a system of quality and reliability testing for the organization's products and/or development processes.
Responsibilities:
? Provide leadership to develop, maintain and improve the Quality Management System and Policy.
? Develop, implement, and manage processes and guidelines to ensure that products meet required specifications for quality, function, and reliability prior to delivery.
? Identify and set appropriate quality standards and parameters for products and product testing processes.
? Coordinate quality audit by customer and/or third-party auditor.
? Conduct internal self-audit for quality management system effectiveness. Document findings in a self-audit report. Initiate CAPA to present non-compliance and product quality problems proactively. Ensure continuous and sustained improvements.
Requirement:
? Bachelor's degree in Business, Engineering, or other equivalent.
? Minimum 10 years of manufacturing operation experience with 5 years+ in senior management position.
? Prior experience in EMS, electronics or medical device industries highly preferred.
? Thorough knowledge of manufacturing and quality standards and regulations such as cGMP, ISO-9001, 13485 and FDA certifications.
? Hand-on experience in validation, IOPQ and reliability engineering.
? Strong in project management, sound timely decision making, delegation and process management.
? Self-driven with strong leadership with excellent verbal and written communication and presentation skills.
? Excellent in spoken and written English and Mandarin.
? Based in Dongguan, occasionally travel to Thailand.
作业摘要：
品质保证（QA）总监/高级经理将监督品质保证部门和员工的活动，开发、实施和维护组织产品和/或开发过程的品质和可靠性测试系统。
职责：
1） 领导制定、维护和改进品质管理体系和政策。
2） 制定、实施和管理流程和指南，确保产品在交付前符合品质、功能和可靠性方面的要求。
3） 为产品和产品测试过程确定并设定适当的品质标准和参数。
4） 协调客户和/或第三方审核员的品质审核。
5） 对品质管理体系的有效性进行内部自检。将调查结果记录在自我审计报告中。启动CAPA，主动提出不合规和产品质量问题。确保持续改进。
要求：
1） 商业、工程或其他同等专业的学士学位。
2） 至少10年制造运营经验，5年以上高级管理职位。
3） 有EMS、电子或医疗器械行业工作经验者优先。
4） 全面了解生产和品质标准及法规，如cGMP、ISO-9001、13485和FDA认证。
5） 在验证、IOPQ和可靠性工程方面积累经验。
6） 项目管理能力强，决策及时，授权和流程管理能力强。
7） 具有较强的领导能力，具有良好的口头和书面沟通及表达能力。
8） 优秀的英语会话和书面表达能力。
5131 5610-|171 4766 7191 219） 在东莞工厂工作，偶尔出差泰国工厂。