Manufacturing Quality Engineer, Swing Shift
Core
Develops, implements, and evaluates tools and equipment for quality assurance and product/process improvement in a life science manufacturing environment.
Role type
Manufacturing Quality Engineer
Builds
Quality assurance tools, equipment, and processes for product expansion and full production.
Domain
Life sciences manufacturing / CGMP regulated environment
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CGMP compliance, process improvement methodologies, SOP creation, nonconformance review, life cycle management, cross-functional partnership
Preferred skills
Digital solutions for manufacturing optimization, continuous improvement methodologies
Technologies
Digital solutions for manufacturing
Responsibilities
Provide QA guidance and oversight to ensure process, data, and product quality; Lead process and product improvements for manufacturing expansion; Support start-up activities as a Quality representative; Improve documentation and processes to meet objectives; Participate in creation and approval of equipment and process SOPs; Support transition of products from prototype to full production; Interface with process materials adhering to safety guidelines; Partner with material management, planning, procurement, and manufacturing to meet timelines and quality policies; Review nonconformance and manufacturing documentation.
Seniority
Mid-level, hands-on IC