Quality Associate II
Core
Lead quality investigations for deviations, nonconformances, complaints, and other quality events to determine root causes and support effective resolution.
Role type
Senior IC Quality Investigation Lead
Builds
Inspection-ready investigation reports and sustainable corrective and preventive actions (CAPAs)
Domain
Pharmaceutical/Medical Device Manufacturing Quality
Required skills
Root cause analysis, risk-based decision making, regulatory compliance (cGMP), data integrity, technical writing, evidence evaluation, CAPA development, cross-functional collaboration, project management, problem-solving
Preferred skills
Regulatory inspection support, investigation methodologies (5 Whys, Fishbone, Fault Tree, DMAIC), data visualization, statistical analysis, Lean Six Sigma Green Belt, ASQ certification
Technologies
TrackWise, eQMS, Microsoft Office
Responsibilities
Lead quality investigations for deviations and complaints; Analyze manufacturing and quality-system data to identify facts and root causes; Assess impact to products, processes, and patients; Recommend CAPAs to reduce risk; Create thorough investigation reports; Partner with cross-functional experts to resolve issues
Seniority
Senior, hands-on IC