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Location: Suzhou, China
Position Type: Fixed-Term
Job Function: Quality
1.岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
Serve as a quality assurance subject matter expert to provide guidance and expertise
Serve as a independent reviewer on account of quality viewpoint in regard to technology transfer and through the whole of product/system life cycle.
Recognize and plan various essential validation activities based on risk assessment and user’s requirement.
2.主要职责 / MAIN ACCOUNTABILITIES
Provide quality expertise in the project to compliance to local medical device regulations and relevance codes.
Participate and support in development on project plan, quality plan and validation plan activities, and supervise corresponding activities according to the plans.
Serves as a member as a quality representative and chairperson, to review deliverables such as project files, validation and qualification documentations etc. against regulations and company internal quality management system procedures.
Assist cross function on the product, equipment and process risk management along all the product/system life cycle.
Serves as a member as a quality representative and chairperson, to coordinate and review quality event, cause investigation, CAPA, quality change control and site level compliant investigation against regulations and company internal quality management system procedures.
Responsible for the quality supervision of the production process, Including the visual inspection of finished products and batch records review etc. to ensure that the product quality meets the technical requirements as product registration.
Supporting supplier and internal audit activities as necessary.
3.知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE
Bachelor’s degree or above, Pharmaceutical or medical device science/engineering or related majors. At least 5 years’ experience as quality management in medical device manufacture industries.
Familiar with GB/T 42061 (ISO 13485) and other quality management system related regulations and standards, preferably with an internal auditor certificate.
Familiar with quality good manufacture practice, including but not limited to "Guiding Principles for On-site Inspection of Good Manufacturing Practice for Medical Devices", "Good Manufacturing Practice for Medical Devices" and their related appendices.
Good English oral and written ability.
Familiar with CFR 21 Part 11 and GAMP is as better.
Familiar with Lean and six sigma quality methodology is as better.