Manufacturing Quality Assurance Lead - Folsom
Core
Lead the local Quality Management System (QMS) for manufacturing Gas Chromatography Columns, Metal Microfluidics, and Bioconsumables, ensuring ISO 9001:2015 compliance and continuous improvement.
Role type
Manufacturing Quality Assurance Lead
Builds
Production of Gas Chromatography Columns, Metal Microfluidics, Sample Preparation, and Bioconsumables
Domain
Life Sciences / Analytical Instrumentation Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 9001:2015 compliance, QMS implementation, CAPA management, Change Control, Risk Management, Process Validation, Audit management, Supplier Quality oversight
Preferred skills
Chemistry or Life Sciences background, Cross-functional collaboration
Technologies
ISO 9001:2015, QMS software platforms
Responsibilities
Own local ISO 9001:2015 QMS processes including Nonconformance Management and CAPA; Ensure effective Training Management and employee qualification processes; Provide QA support for production issues and product investigations; Monitor product quality and process controls through direct engagement with manufacturing; Oversee incoming, in-process, and QC inspections; Lead audit management activities including preparation and hosting; Represent QA in customer interactions for QMS questionnaires and agreements; Support Design Transfer activities for new products.
Seniority
Senior, hands-on IC