Director, Central Quality Audit

Responsibilities

• Execute GEHC's Central Quality & Regulatory Audit program, including scheduling, preparation, reporting, and follow-up activities
• Support Health and Competent Authority audits, managing back-room activities and tracking Lessons Learned
• Define and maintain metrics for GEHC Quality Management System to enhance visibility of Quality & Regulatory issues
• Lead functional teams or projects with high risk and complexity, influencing strategy and policy formulation
• Utilize judgment and problem-solving skills to assess quality information and make informed decisions
• Promote strong Quality & Regulatory practices through mentorship and collaboration

Qualifications

• Qualified Lead Auditor with active certification
• Master’s Degree with 5 years experience in medical devices or Bachelor's Degree with 10 years experience; High School Diploma with 15 years progressive experience is also considered
• 5+ years leading global programs for quality compliance issues
• Proficiency with medical device QMS and regulatory requirements, including FDA CFR 21 820 and ISO 13485

Benefits

• Comprehensive medical, dental, and vision insurance plans
• 401(k) plan with employee and company contribution opportunities
• Paid time off for work-life balance
• Tuition reimbursement for professional development
• Life, disability, and accident insurance