Responsibilities  

• Work directly and closely with supplier's (Southern China based) different functions on site including but not limited to manufacturing, purchasing, quality, and supply chain, etc. to make sure facilities, processes and products (FDA listed) are executed per the documented approaches
• To monitor supplier’s overall performance in area of Production Capacity, Productivity, Delivery Performance and New Product Introduction areas.
• Ability to make sound direction and decision in compliance with the GMP, traceability, production engineering, quality improvements and furthermore to contribute to the necessary development of the system in general for FDA regulated products
• To review and validate for supplier’s production processes are optimized. To identify operating risks and implement relevant controls with supplier. Responsible in monitoring daily surveillance checks and preventive operation program.
• To work with supplier to make sure customer’s complaints are reviewed and corrective actions are taken.
• Manage competing priorities to ensure targets and timelines are met.
• Ensure process / component changes as requested by suppliers have the appropriate level of technical assessment, control, and approval.
• In co-ordination with the Quality Manager, plan and conduct periodical audit to identify process gaps and improvement areas.
• Map production constraints and monitor supplier production and delivery performance to ensure agreed output are achieved with right quality.
• Initiate periodical review meeting with supplier over operation issues and ensure corrective actions are taken

Requirements: 

• Degree holder in engineering related, and at least 3 years of experience in the medical device or pharmaceutical industry, or an equivalent combination of education and experience.
• Managing a cGMP supplier team and process is essential.
• Prior actual FDA audit experiences would be preferred.
• Superior English and Mandarin skills is a “must have”.
• Robust understanding of CAPA and NC protocols, standard practices, and root cause analysis investigation techniques.
• Ability to work independently and cross-functionally in a dynamic environment.
• Flexibility in problem solving, providing direction and work hours to meet business objectives.
• Need to station in Southern China to work closely with supplier's production site.

We offer competitive remuneration package, 5-day work and medical insurance to the successful candidate. Interested parties, please send your Resume with expected salary. 

Personal data will be used for recruitment purpose only.

We focus in Consumer Electronics Supply Chain Management Service to overseas clients. We provide ODM and OEM service to customers. We are a profession team with in-house technical resources and test facilities to evaluate product development from design, prototyping till mass production stages. To cope with our operation expansion, we are looking for the candidates to support our business growth.