Job ID :
China - Shanghai
- To establish and improve the quality processes for SC operation which including but not limited to warehousing management, cold chain management, local language labeling process, product delivery, validation.
- To deploy and enhance quality control plan based on product safety and compliance risks to ensure the products released to the market from China distribution centers are comply with both China regulatory and Medtronic requirements.
- To lead team to conduct product release activities including: 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 processes in product receiving, storage, shipping, etc, are in full compliance to regulatory and corporate quality requirements.
- To be responsible to local language labeling process to ensure its process design, system functionality, source data, process execution are fully compliant with GMP requirements.
- Conduct medical device risk analysis for NC products. Lead and/or support CAPAs investigation and follow up within distribution operations.
- Act as the quality representative for one legal entity and take fully legal quality responsibility for that legal entity. Which means to make sure the legal entity fully comply with patient safety and regulatory requirements with efficient quality system be set up and maintained.
- To provide support China quality objectives and quality function strategies as well as initiatives from local business.