Sr. QA Specialist
Core
Develop and maintain systems, rules, and processes to ensure compliance with internal and external requirements, specifically focusing on deviations, complaints, and manufacturing quality in a medical technology context.
Role type
Senior Quality Assurance Specialist (Medical Devices/Pharma)
Builds
Quality assurance systems, deviation management processes, and product release decisions
Domain
Medical technology / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, deviation/OOS/CAPA management, complaint investigation, supplier coordination, audit management, batch record review, continuous improvement, SOP revision
Preferred skills
QA/QC experience, cross-departmental project leadership
Technologies
Microsoft Office Suite
Responsibilities
Handle deviation/OOS/CAPA to ensure compliance with cGMP; Handle product complaints and communicate responses; Coordinate with suppliers for investigations; Lead cross-department projects; Liaise with Operations for regulatory compliance; Monitor manufacturing processes and data integrity; Participate in internal and external audits; Review batch manufacturing records for release/rejection decisions
Seniority
Senior, hands-on IC
