Company: Dizario Search
Location: Fort Collins, CO
Dizario Search is looking for an experienced Quality Manager to join a small, growing medical device manufacturer with a strong focus on injection molding.
This is a great opportunity for a hands-on quality professional who enjoys working in a smaller manufacturing environment, partnering closely with operations and engineering, and having a direct impact on product quality and regulatory compliance.
The Quality Manager will lead the company’s quality function, ensuring that products are manufactured consistently to customer, quality, and regulatory requirements. This person will work closely with manufacturing, engineering, and other cross-functional teams to identify issues, drive corrective actions, improve processes, and maintain a strong quality culture.
Key Responsibilities
Lead the Quality Management System (QMS) and ensure compliance with applicable medical device regulations and quality standards.Oversee quality activities related to injection molding, including process controls, inspections, nonconformances, and process improvements.Manage CAPA, nonconformances, root-cause investigations, and corrective/preventive actions to drive sustainable improvements.Support internal, customer, and regulatory audits, including preparation, responses, and follow-up actions.Partner with Operations and Engineering to improve manufacturing processes, reduce defects and scrap, and ensure consistent product quality.
Qualifications
Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical field5+ years of quality experience in manufacturing, with experience in a regulated manufacturing environmentMinimum 2 years in a quality manager roleStrong knowledge of ISO 13485, FDA requirements, quality systems, and injection molding processes is a plus!