QA Engineer, Environmental Control III
Core
Develops and implements quality plans, programs, and procedures for environmental control and clean room monitoring to ensure product quality and contamination control.
Role type
Senior IC Quality Engineer (Environmental Control & Microbiology)
Builds
Clean room performance and product quality conformance
Domain
Manufacturing / Environmental Control / Microbiology
Required skills
Quality control statistics, contamination control processes, microbiology, chemistry, process validation/qualification, CAPA management, ISO 9001/13485 compliance, FDA audit support, data analysis and trending
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develops and maintains quality evaluation and control plans for environmental and microbiology equipment; Audits quality systems for contamination control deficiencies; Investigates environmental and microbiology control failures and develops corrective actions; Interfaces with manufacturing, engineering, and customer representatives to ensure requirements are met; Supports Safety, Health, and Environment (EHS) programs.
Seniority
Mid-Senior, hands-on IC