Director, Quality Assurance

Description MAC Medical, Inc. Director of Quality Assurance & Regulatory Affairs Classification: Exempt Reports To: President Location: Millstadt, Illinois Position Summary Provides strategic leadership of the Quality Management System (QMS), regulatory affairs, compliance programs, certifications, supplier quality governance, and customer quality systems. Essential Functions Own the corporate QMS. Lead FDA and ISO compliance. Manage regulatory submissions and audits. Maintain document control and change control. Own CAPA governance and Management Review. Oversee supplier qualification and audits. Manage customer complaint system. Develop executive quality metrics. Lead Quality Assurance personnel. Partner with Operations on quality improvement. Requirements Required Qualifications Bachelor's degree in Engineering, Quality, or related field. 7–10+ years in medical device quality/regulatory leadership. Experience with FDA, ISO 13485, and 510(k). Strong leadership and communication skills. Key Performance Indicators Audit results CAPA effectiveness Customer complaint trends Supplier quality QMS compliance #J-18808-Ljbffr