Quality Specialist III - Engineering Support
Core
Maintain regulatory compliance and drive continuous improvement of quality systems to support the mission of enabling customers to make the world healthier, cleaner and safer.
Role type
Senior IC quality specialist (regulated industries)
Builds
Quality systems, corrective actions, and audit readiness for pharmaceutical, medical device, and biotech operations
Domain
Life Sciences / Regulated Manufacturing
Required skills
GMP/GxP regulations, ISO standards, quality management systems, CAPA processes, deviation management, change control, root cause analysis, statistical analysis, technical writing, audit management, risk assessment, continuous improvement tools
Preferred skills
Life Sciences, Engineering, Chemistry, Biology, project management
Technologies
TrackWise, Document Control Systems, Microsoft Office Suite
Responsibilities
Investigate quality issues, conduct audits, manage documentation, implement corrective actions, author SOPs and investigation reports, host regulatory inspections
Seniority
Senior, hands-on IC