Quality Manager

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic individual to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities The Quality Manager is responsible for leading all Quality Assurance (QA) and Quality Control (QC) activities to ensure compliance with customer requirements, regulatory standards, and company quality objectives. This is a hands‑on leadership position requiring active participation in daily quality operations, including inspections, validations, problem solving, customer support, and continuous improvement initiatives. As a working manager in a small manufacturing environment, the Quality Manager is expected to actively participate in day‑to‑day quality activities while providing leadership, direction, and continuous improvement for the Quality Department. The Quality Manager works closely with Production, Tooling, Purchasing, and Executive Management to maintain product quality, improve manufacturing processes, and promote a culture of quality throughout the organization. Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO standards, regulatory requirements, and customer specifications. Lead daily quality activities, including inspections, validations, First Article Inspections (FAI), Production Part Approval Process (PPAP) submissions, process capability studies, and statistical analysis. Lead root cause investigations and implement effective Corrective and Preventive Actions (CAPA). Serve as the primary quality contact for customers and suppliers, supporting audits, quality reviews, complaints, and corrective actions. Supervise, train, and mentor Quality Auditors while promoting quality awareness throughout the organization. Ensure calibration and proper use of inspection and metrology equipment. Review and approve quality documentation, including validation reports, Control Plans, PFMEAs, inspection procedures, and customer submissions. Monitor quality performance indicators (KPls) and prepare reports for Executive Management. Drive continuous improvement initiatives focused on reducing scrap, improving yield, and enhancing process capability. Provide hands‑on support to production during process troubleshooting and critical quality issues. Advise Executive Management on quality risks, regulatory compliance, customer concerns, and continuous improvement opportunities that support the Company's strategic objectives. Qualifications Bachelor's degree in Engineering, Quality Management, or a related technical field preferred; equivalent manufacturing experience may be considered. Minimum five (5) years of Quality experience in injection molding or plastics manufacturing. Supervisory or leadership experience preferred. Strong knowledge of IS Quality Systems, SPC, PPAP, PFMEA, GD&T, CAPA, validation activities, and metrology equipment. Fluent in both English and Spanish (written and verbal), with the ability to communicate effectively with customers, suppliers, auditors, and employees at all organizational levels. Excellent leadership, communication, analytical, organizational, and problem‑solving skills. Ability to work effectively in a fast‑paced, hands‑on manufacturing environment. 1st shift but candidate must be available to work 2nd or 3rd shift if needed. Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. #J-18808-Ljbffr