Engineering Leader

Company: MicroPort
Location: Irvine
Posted on: January 15, 2022

Job Description:

Summary:This position belongs to MicroPort US Headquarters with Manufacturing, R&D, and Administration functions;Location---Irvine, CA 92606, USA
Job Responsibilities:Process management1). Establish production process and related process documents for products.2). Establish raw material quality standards for products and establish raw material adaptability evaluation system.3). Charge in production process validation.4). Continuously improve the process to improve product yield rate and reduce production cost.5). Charge in risk management, collect data of nonconforming products and analyze, implement CAPA.6). Ensure that the work related to process management meets the requirements of QSR820, ISO13485 and other quality management systems. Equipment management1). Equip equipment according to production plan, and manage the procurement, installation, maintenance and other related work of equipment.2). Participation in risk analysis, collect data of equipment failure and analyze, implement CAPA.3). Manage equipment spare parts, establish appropriate safety inventory of equipment spare parts in order to repair equipment in time and control the inventory amount of equipment spare parts at the same time.4). Ensure that the work related to equipment management meets the requirements of QSR820, ISO13485 and other quality management systems. Human resource management1). Prepare manpower matching the production plan.2). Improve subordinates' skills and work enthusiasm.3). Manage the work performance of subordinates. Qualifications:1. Master's degree or above in Polymer, Chemistry, Pharmacy or related engineering fields.2. Minimum 10 years' experience in process management and equipment management relative job, drug stent experience related is preferable.3. Familiar with six sigma and ISO13485, FDA QSR 820---Part 211. is preferred.4. Strong innovation, analysis ability.

• Good communication and organization ability.
• Adapt to new environment quickly with strong leadership in change management
  About MicroPort -:MicroPort - was founded in a very small office in Shanghai, China in 1998 when a group of dedicated individuals joined together by the common belief that advancements in medical technology could transform patients' lives. Over the last two decades, MicroPort - has taken important steps towards fulfilling its mission of providing trustworthy and universal access to state-of-the-art solutions of prolonging and reshaping all lives.MicroPort was listed on the main board of Hong Kong Stock Exchange in 2010. Currently we have 2 subsidiaries spun off and separately listed on the mainland Hong Kong Stock Exchange respectively.

Keywords: MicroPort, Irvine , Engineering Leader, Engineering , Irvine, California