Head of Quality

The Company is seeking a Site Head of Quality to join their dynamic team. The successful candidate will be a key member of the senior leadership, responsible for the oversight of the Quality Management System to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other global regulatory standards. This role is pivotal in driving quality excellence in the production of Class II medical devices, with a strong focus on patient safety and scalability to meet market demand. The Site Head of Quality will develop and execute quality strategies, lead a team of 12-15 quality professionals, and oversee all QA functions at the manufacturing site. They will also be involved in premarket and post-market quality activities, lead supplier quality programs, and serve as the primary QA representative during regulatory inspections and audits. The ideal candidate for this role at the company will have a Bachelor’s degree in engineering, science, or a related technical discipline, with an advanced degree preferred. A minimum of 10 years' progressive quality leadership experience in the medical device industry, particularly in a manufacturing environment for Class II or Class III devices, is required. The candidate should have a deep expertise in regulatory standards, a proven track record of leading and mentoring QA teams, and strong knowledge of manufacturing quality processes. Exceptional strategic thinking, problem-solving, and decision-making skills are essential, as is the ability to champion continuous improvement initiatives and foster a culture of quality and compliance. Professional certifications in quality engineering or management, as well as Lean/Six Sigma certification, are preferred.