Manufacturing Quality Assurance (QA) Lead - Shanghai
Core
Lead the local ISO 9001:2015 Quality Management System (QMS) for manufacturing Columns and Consumables for Gas Chromatography, Liquid Chromatography, and Life Science instrumentation.
Role type
Manufacturing Quality Assurance Lead
Builds
Manufacturing processes for analytical instrumentation
Domain
Life Sciences / Analytical Instrumentation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 9001:2015 compliance, QMS process ownership, audit management, CAPA implementation, Change Control, Risk Management, Process and Equipment Validation, Supplier Quality collaboration, Product Investigations, Design Transfer support
Preferred skills
Chemistry or Life Sciences background, cross-functional collaboration
Technologies
ISO 9001:2015, QMS software platforms
Responsibilities
Own local QMS processes including Nonconformance Management, CAPA, Change Control, Training, Risk Management, and Validation; Ensure effective Training Management process; Provide QA support to Manufacturing for production issues; Collaborate with Supply Chain for shipment holds and product investigations; Monitor product quality and process controls; Oversee incoming, in-process, and QC inspection; Monitor and report Quality and Customer Experience data; Lead audit management activities; Represent QA during customer interactions; Support Design Transfer activities; Collaborate with Supplier Quality
Seniority
Mid-level, hands-on IC