Operation Quality Manager--某美资大型医疗企业


- To establish and improve the quality system for SC operation which includingbut not limited to warehousing management, product delivery and relabelingprocess.
- To deploy and enhance quality control plan based on product safety andcompliance risks to ensure the products released to the market from Chinadistribution centers are comply with both China regulatory and Companyrequirements.
- To lead team to conduct product release activities including: Import productcode release, Incoming inspection release, Product Hold Order handling,Non-conformity Handling, Return product handling, Product scrap, etc.
- To partner with SC operation team to ensure warehousing operation processesin product receiving, storage, shipping, etc, are in full compliance toregulatory and corporate quality requirements.
- To be responsible to local language labeling process to ensure its processdesign, system functionality, source data, process execution are fullycompliant with GMP requirements.
- Conduct medical device risk analysis for NC products. Lead and/or supportCAPAs investigation and follow up within distribution operations.
- Be accountable for maintaining distribution permits of MDT China and receiveexternal inspections from regulatory authorities.
- Act as quality partner for either business group or function to make sure theimportant quality elements are covered by BU/function in their strategy andtheir daily work. Support BU to handle the quality related process, toughcases, and thus meet the BU/function needs.
- Act as the quality representative for one legal entity and take fully legalquality responsibility for that legal entity. Which means to make sure thelegal entity fully comply with patient safety and regulatory requirements withefficient quality system be set up and maintained.
- To provide support the quality system objectives and quality functionstrategies as well as initiatives from local business.
- Medical device industry 8+ years quality experience
- 3-5 years of practical medical device manufacturing experience as plantquality manager
- Working knowledge of CFDA medical device GMP&GSP regulations and how tointerpret and monitor them with experience or knowledge in Quality Systemsrelating to medical device GMP&GSP and ISO.
- Understanding and implementation experience in the following tools ispreferred: FMEA, control plan design, process capability improvement, 5S,kaizen, kanban, value stream management, poka-yokes, etc.
- The candidate should have a Bachelor’s Degree in related life science oradvanced technical degree or equivalent.
- Strong understanding on China medical device GMP and GSP requirements.
- Prior knowledge and understanding of the Medical Device or equivalentregulated industry, Quality Systems is preferred.
- The ability to lead a cross-functional team is required.
- Fluent oral and written English