Sr. Microbiology Quality Engineer
Core
Leading and managing Complaint Defect Tracking & Resolution (CDT&R) activities, including complaint triage, trend analysis, and coordination of investigations for post-market quality issues in life sciences diagnostics and biotechnology.
Role type
Sr. Microbiology Quality Engineer
Builds
Customer-facing technical reports and investigation summaries ensuring regulatory compliance for medical devices and pharmaceuticals.
Domain
Life sciences / Diagnostics / Biotechnology / GMP
Deliverable
client delivery
Required skills
Microbiology laboratory competence (microscopic differentiation, Gram staining, environmental monitoring), Root cause analysis, CAPA planning, Field action management, Risk assessment, Statistical data analysis, cGMP/ISO 13485 quality systems knowledge
Preferred skills
Advanced statistical analysis tools (Minitab), Quality engineering certifications, USP 61 & 62 knowledge
Technologies
Microsoft Excel, PowerPoint, Word, Teams
Responsibilities
Lead CDT&R activities including complaint triage and trend analysis; Author and review investigation summaries and customer-facing reports; Provide subject matter expertise on containment actions and investigation execution; Manage field actions and facilitate formal risk assessments; Generate and present quality metrics related to nonconformances and CAPAs
Seniority
Senior, hands-on IC
