Associate, Quality Operations
Core
Ensure design transfer and manufacturing operations of medical devices meet Alcon standards and regulatory requirements (21 CFR Part 820, ISO 13485, MDR) across the product lifecycle.
Role type
Associate Quality Operations Specialist
Builds
Medical device manufacturing operations compliant with quality and regulatory standards
Domain
Medical Devices / Eye Care
Required skills
Quality Assurance, cGMPs, ISO13485, 21 CFR Part 11, ISO9001, Change Control, Document Control, Non-conformance management, Validation protocols, Risk assessment, Audit support, KPI analysis
Preferred skills
Pharmaceutical industry experience, Medical Device industry experience, Calibration oversight, Preventive maintenance oversight
Technologies
QMS systems, Validation software, Audit management tools
Responsibilities
Provide operational support for product release; Conduct investigations for non-conformances, FAAs, and customer complaints; Review and approve validation protocols and reports; Provide e-compliance oversight for CSV activities; Support internal and external audits and finding closure; Trend and analyze key performance indicators to suggest improvements.
Seniority
Mid-level, hands-on IC