Sr. Associate, Quality Assurance Engineering
Core
Develop, modify, and maintain quality evaluation and control systems; devise inspection methods; manage product quality risks for ASPEX production and laboratories.
Role type
Senior Associate, Quality Assurance Engineering (Science/Tech/Engineering Path)
Builds
Quality evaluation and control systems/protocols, inspection and testing processes, mechanisms, and equipment
Domain
Medical devices / Ophthalmic products / Manufacturing Quality Assurance
Required skills
Statistical analysis, Root cause analysis, Corrective and Preventive Actions (CAPAs), Good Practice (GxP) compliance, Standard Operating Procedures (SOP) adherence, Validation and verification, Third-party supplier investigation management, Product precision and accuracy testing
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develop, modify, apply, and maintain quality evaluation and control systems/protocols; Design and analyze inspection and testing processes, mechanisms, and equipment; Conduct quality assurance tests and perform statistical analysis to assess control levels and manage product quality risks; Undertake root cause analysis of incidents requiring corrective action; Review and approve investigations, ensuring timely completion of CAPAs, validations, and verifications; Adhere to GxP regulations by following SOPs, maintaining accurate documentation, and completing required training.
Seniority
Senior Associate, hands-on IC