Director of Quality Assurance & Regulatory Affairs

About the role

Provides strategic leadership of the Quality Management System (QMS), regulatory affairs, compliance programs, certifications, supplier quality governance, and customer quality systems.

Responsibilities

• 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

• 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

Reports to: President
Location: Millstadt, Illinois
Classification: Exempt