招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
You are responsible for
?Responsible for establish and maintain the QMS according requirement from ISO13485, US FDA 21 CFR part 820, MDSAP, 93/42/EEC (MDD), new MDR, Brazil GMP, Japan J-PAL Ordinance 87, YY/T0287 etc.
?Annual plan internal audit program, driving internal auditor qualification, schedule internal quality system audit activities, and audit finding response.
?Overall coordinate corporate, third party audit and regulatory agency inspections, include audit planning, audit execution, and audit finding response.
?Lead DI PQMS Procedures, E2E Project deployment in site QMS, such as Document Control E2E, data warehouse E2E etc.
?Monthly collect and monitor site KPI, and interface with global quality team for quality dashboard reporting.
?Maintain the quality management system compliance by ensuring the quality procedures are implemented and followed
?Initiate QMS process improvement as required.
?The development of the solution requires a multi-disciplinary approach and knowledge of Quality Assurance principles, -theories and -concepts.
?May lead multi-disciplinary QMS change projects, managing a number of people. Works independently and provides consultative advice within specific functional areas.
?Introduces QMS requirements/procedures that are new for the organization. Applies advanced Quality Assurance process principles to multiple tasks.
?Other task assigned by line manager
To succeed in this role, you should have the following skills and experience
?BS/MS degree or equivalent in Engineering or equivalent experience.
?Strong quality management experience, minimum 8+ years relevant experience with 5 + year in medical industry quality control or in a similar field.
?Evidence of practical knowledge of standards and regulations pertaining to the medical device industry. This includes but is not limited to FDA, CFDA, ISO13485, MDD, JPAL, Brazil GMP, etc
?Proficiency with quality system management is preferred.
?Knowledge and experience in quality control disciplines (e.g. production and process quality control, design quality control, post market surveillance quality control) is advantageous.
Skills:
?Demonstrated experience in leading cross-functional teams for problem solving, with excellent team- work spirit.
?Strong written, verbal, and interpersonal skills while communicating in both English and Chinese.
?Good document writing skills, including clear logic and quality & regulatory compliance.
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