Position Responsibilities:
-Provide quality support in the areas of process control, process verification and validation, design transfer, risk management, and specification development for new product launch.
-Responsible for sustaining quality operation activities including Quality Control Process, Risk Management File, Supplier Management Procedures establish and optimization, support and review product/process/supplier related requests for change.
-Collaborate with engineering, QC, MFG team to improve product & process by driving SCAR, both MFG and Supplier Related NC, Quality Investigation and CAPA investigation. Ensure product disposition and quality Issue could resolve in time.
-Trend, analyze and report MFG and supplier related quality data to improve product and process, collaborate with Global team for supplier quality performance review and improvement
-Involved in supplier onboard, collaborate with purchasing team for supplier quality agreement sign-off. Lead or review supplier material qualification activities, eg. Material/Component specification discussion, process validation, FAI or supplier audit.
-Provide management with status update and escalate issues in a timely manner
-Collaborate with counterparts and cross-functional teams at other Illumina sites.
Illumina）
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Education:
-Bachelor’s degree in biochemical engineering/mechanical/electrical engineering
Preferred Requirements:
-5+ years of relevant experience of quality assurance/ quality control experience in IVD manufacturing environment, instrument MFG experience is preferred.
-Practical experience of in supplier management, process quality control, NC and CAPA
-Highly effective communication, facilitation and coaching skills, collaboration on teams in multiple/global locations is desired.
-Good understanding of GMP and ISO13485.