QMS Manager
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东莞市 |
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2024-04-28 |
Seniority level职位级别 | 中高级 |
Industry公司行业 | 半导体 |
Employment type职位性质 | 全职 |
Function工作职能 | |
Number招聘人数 | 1 |
The Quality Management System (QMS) Manager plays a crucial role in ensuring the compliance, efficiency, and effectiveness of the Quality Management System within Quasar. Reporting to the Director of Quality, the QMS Manager oversees all aspects of the QMS, driving continuous
improvement initiatives and maintaining regulatory compliance to meet industry standards and requirements.
Bachelor degree in Engineering or Life Sciences or related field; advanced degree preferred.
Minimum of 5-10 years of experience in quality management within the medical device industry.
In-depth knowledge of ISO 13485 and other relevant regulations and standards (e.g., US FDA QSR, MDSAP, NMPA etc.).
Experience leading QMS implementation and maintenance activities, including audits and inspections.
Strong analytical skills and attention to detail, with the ability to identify problems, analyze data, and implement effective solutions.
Excellent communication (English) and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
Proven leadership abilities, with experience in driving continuous improvement initiatives and managing complex projects.
Certification as a Quality Auditor (e.g., ISO / ASQ Certified Quality Auditor) is preferred.
Familiarity with risk management principles and tools (e.g., PFMEA, DFMEA, HACCP) is desirable.
Proficiency in Microsoft Office applications and experience with quality management software systems is a plus.