Quality Manager

Responsibilities Responsible for compliance with the requirements of 21CFR Parts 110/111 and 210/211. Works closely with the Quality Managers and the Production Department to ensure Quality Assurance compliance with regulatory and customer requirements. Ensures the content and executional effectiveness of the QA Programs. Responsible to ensure products meet quality and efficiency standards set by the company. Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories. Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures. Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints. Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re‑validations. Direct and supervise Quality Assurance Team. Reviews and updates QMS SOPs, WIs, and Forms, as required, to match current practices. Maintains Major Equipment and Portable Equipment Log books. Collaborates with the Engineering Administrator and Director of Quality, to ensure compliant validation/qualification of all appropriate equipment and/or processes. Qualifications Bachelor’s degree, required or equivalent combination. 3‑5 years Quality experience required. Supervision experience required. Experience in managing various levels of employees with different educational backgrounds, work style habits, and employment histories. #J-18808-Ljbffr