Responsibilities:

• Maintain compliance of QMS including manufacturing site; upgrade the procedures; organize Management Reviews, planning and supervising internal audits and CAPA

• Contributing to regulatory compliance of medical devices under MDD/MDR and FDA requirements as a member of Global QARA Team

• Responsibility for achieving due certificates of a Notified Body and maintaining FDA compliance / approvals.

• Control over quality of products in the manufacturing site including customer complaints & feedback and reporting trends

• Lead and supervise of process and product validations as well as of continuous improvements in the manufacturing site from quality, regulatory and business perspective

• Manage the selection and development of people, resources and budgets necessary to meet company’s strategic objectives. Assign and directs work activities for the team, while ensuring accountability for decision making and appropriate cross-functional communication

Qualfications:

• Bachelor degree preferably in engineering or related; master degree is preferred.

• Profound knowledge of ISO13485,21 CFR Part 820, MDD / MDR; Internal Lead Auditor,

• Very good English spoken and written

• Project Management Leadership Experience, PhD degree,

• Over 8 years’ experience as quality and regulatory Manager in sterile medical devices area

• QMS Management Representative; successful record of FDA and/or CE audits

• Understanding of manufacturing processes and experience in validations.Successful record of product launches

• Records of unassisted successful product certification under MDD or FDA.

• Experience in managing Technical Files and co-operation with R&D. Experience in leading international teams; understands business needs; strategic.

• Experience in clean room environment requirements.External auditing experience

• Successful record of managing OEM co-operation (as supplier or customer). Exposure to, or experience in, Operations, Finance, and R&D

• Taking fully responsibilities for decision & results; innovation in process; building a culture of accountability and focus on quality. Promoting process-driven behaviours and culture.

上班地址：松江区新桥新蟠路189号