Primary Staffing

Compensation

Full Description

Join our team as a Quality Manager and lead our efforts to ensure the highest standards of product and process quality. This role is ideal for an experienced professional ready to take ownership of quality systems and lead cross-functional improvements. Responsibilities: • Lead the Quality Department and work collaboratively with other departments. • Manage and maintain ISO-9001, GMP, and ISO-13485 QMS. • Lead annual audits and oversee the Quality team. • Support the development and execution of quality control standards, policies, and procedures in compliance with 21 CFR Part 820.180 & 820.198 / GMP requirements for Class 1 Exempt Medical Devices. • Mentor and manage a team of quality control engineers, technicians, and inspectors. • Collaborate with Operations, Manufacturing, Sourcing, Sales, and Engineering to resolve quality-related issues. • Establish and monitor KPIs to improve product/service quality and efficiency. • Conduct inspections and audits to identify defects or non-conformities. • Analyze trends and recommend corrective/preventive actions. • Support training initiatives to ensure quality standards are understood and followed. • Work with suppliers and vendors to ensure quality of incoming materials. • Prepare and present quality control reports to senior management. Requirements: • Bachelor's degree in Engineering or related technical field. • Minimum of 5 years of experience in a managerial or supervisory quality control role. • Experience with GMP and ISO 13485 audits. • Strong knowledge of quality control standards, methodologies, and regulations. • Proven leadership and team management skills. • Effective communication and ability to work cross-functionally. • Experience with Microsoft Office (Excel, Word, PowerPoint).