Head of Site Quality

The Company is seeking a Head of Site Quality to take on a pivotal leadership role in the quality function at one of its key manufacturing sites. The successful candidate will be the site's Quality Management Representative, overseeing the Quality Assurance, Quality Control, and Quality Laboratory teams to ensure a compliant, robust, and continuously improving Quality Management System. This role involves strategic partnership with global leadership, hosting audits, and building a high-performing team that is dedicated to quality and takes pride in its work. The ideal candidate will have a Bachelor's degree in a relevant field or 10+ years of equivalent experience, with a minimum of 7 years in a quality, quality engineering, or manufacturing operations role within a regulated environment, and at least 5 years of leadership experience. Applicants for the Head of Site Quality position at the company should be adept at blending compliance, continuous improvement, and people development. The role requires a strong knowledge of ISO 9001 & ISO 13485, FDA regulations, cGMPs, and CFR requirements, as well as proficiency in quality statistical methods, Lean Manufacturing, Six Sigma, Gage R&R, and Root Cause Analysis tools. The successful candidate will be responsible for implementing, maintaining, and optimizing the Quality Management System, and must have a proven track record of leading, coaching, and mentoring teams, managing performance, and effectively communicating at all levels. This is an excellent opportunity for a quality leader to make a significant impact and drive customer-centric solutions in a dynamic and challenging environment.