Associate I, Quality
Core
Provide quality support and oversight via process/area projects and process development to ensure products meet regulatory standards and patient safety requirements.
Role type
Associate I, Quality (Quality Assurance/Operations)
Builds
Quality processes, Standard Operating Procedures (SOPs), and corrective action plans for global operations.
Domain
Healthcare manufacturing / Quality Assurance
Required skills
Risk assessment, process evaluation, SOP development, audit support, corrective action planning, data analysis, regulatory compliance knowledge, team supervision, 6S principles
Preferred skills
Engineering or science degree, FDA regulations knowledge, GMP/GLP application, computer proficiency, problem-solving
Technologies
None explicitly stated
Responsibilities
Identify and assess regulatory and quality risks; lead daily departmental operations; supervise assigned personnel; perform internal assessments and evaluations; determine logic and effectiveness of processes; develop plans to correct identified risks; write and revise SOPs; support external audits; serve as Subject Matter Expert (SME) and provide training.
Seniority
Entry-level to Junior, hands-on IC
