Quality Assurance Specialist II
Core
Provide primary Quality Operations support for Filtration and D&M manufacturing units, ensuring compliant and timely manufacturing activities, documentation, data review, and issue resolution.
Role type
Quality Engineering Specialist (Manufacturing)
Builds
Compliant manufacturing operations for life sciences diagnostics and biotechnology products
Domain
Life Sciences / Biotechnology / Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) operations, root cause analysis, CAPA management, risk assessment, change control, complaint handling, nonconformance assessment, cross-functional collaboration, cleanroom/controlled environment oversight, electronic quality systems proficiency, data analysis, continuous improvement execution
Preferred skills
DBS (Danaher Business System), Lean Six Sigma, Toyota Lean System, Cleanroom Management, Life Sciences/Pharmaceuticals/Medical Devices domain expertise
Technologies
Electronic quality systems, AI-enabled tools, digital data analysis tools
Responsibilities
Provide day-to-day Quality Operations support for manufacturing floor, documentation review, and quality issue triage; Lead or support investigations and nonconformance assessments including problem statement development and closure; Partner with Manufacturing, Engineering, and Laboratory teams to drive cross-functional issue resolution; Identify and execute continuous improvement opportunities using quality system data and investigation outcomes
Seniority
Mid-Senior level (5-10 years experience)
