Quality Assurance Manager

Job Title/High-Level Position Summary:The Quality Assurance Manager is responsible for managing, developing, implementing, and maintaining technical systems and activities for a small Quality Assurance and/or Quality Control group.Key Responsibilities:Defines and specifies the implementation of standards, methods, and procedures for inspecting, testing and evaluating the quality, precision, accuracy and reliability of company products. Ensures compliance with Company standards and government regulations. Participates in the reviewing and assessing of engineering designs. Assists product support areas in gathering and analyzing data. Responsible for monitoring and reporting on product quality, performance and reporting on this through management review. Candidate must have a strong understanding /knowledge of FDA device requirements, ISO 13485, MDSAP and will be required to represent the business in audits of these areas. It is essential that they have a solid understanding of root cause analysis, CAPA and none-conforming product management. Has typically authority of a manager including hiring, disciplining, and terminating. Has budgetary responsibility. Minimum Qualifications:8+ Yrs of Work Exp in QA with a specific focus on Medical Devices BS/BA Desired Characteristics:5+ yrs of mgmt. exp Lean or 6 Sigma Certification

Created: 2025-09-26