1 insurance jobs found in Gardner

Overview The Senior Quality Management Systems Engineer is responsible for maintaining, improving, and ensuring compliance of the company’s Quality Management System in accordance with ISO 9001, ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.  This role supports continuous improvement initiatives, internal and customer audits, CAPA processes, and documentation control to ensure product quality and regulatory compliance. This position is responsible for developing and maintaining the company’s QMS documentation including SOPs, work instructions, and related forms and specifications The position is also responsible for ensuring individuals within the company are effectively trained to the QMS documentation applicable to their roles and responsibilities. Principal Responsibilities Quality System Maintenance & Compliance Maintain and improve the company’s Quality Management System (QMS) to ensure...