Senior Quality Assurance Manager

We are seeking an experienced and results-driven Senior Quality Manager to lead all site quality functions within a manufacturing environment. This role serves as the site’s Quality Management Representative and is responsible for driving a culture of quality, continuous improvement, and operational excellence while ensuring compliance with customer, corporate, and regulatory requirements. Key Responsibilities Lead all quality functions, including Quality Control, Quality Engineering, Validation, Metrology, and Quality Systems Drive continuous improvement initiatives to enhance product quality, operational efficiency, and customer satisfaction Develop and monitor quality metrics, KPIs, and performance objectives Maintain and improve the Quality Management System (QMS) to ensure compliance with applicable standards and regulations Serve as the primary point of contact for audits, regulatory inspections, and customer quality matters Lead internal audits, corrective actions, and compliance initiatives Support customer complaint investigations, root cause analysis, and corrective actions Provide technical quality support for manufacturing, including validation, process improvements, SPC, and data analysis Build, mentor, and develop a high-performing quality team Deliver training programs and support employee development within the quality organization Qualifications Bachelor’s degree in Engineering, Quality, Science, Business, or a related technical field Minimum of 7 years of experience in quality management within a manufacturing environment At least 3 years of leadership experience managing a team Experience in regulated industries such as medical device, pharmaceutical, or healthcare packaging preferred Strong knowledge of Quality Management Systems and regulatory standards (FDA 21 CFR Part 820, ISO 13485, ISO 9001) Experience with validation, Statistical Process Control (SPC), process capability, and continuous improvement tools Proficiency with ERP systems, QMS platforms, and Microsoft Office #J-18808-Ljbffr