Director, Central Quality Audit

Role Overview

• Manages, ensures and improves capabilities to comply with external standards and regulations
• Executes against GEHC's Central Quality & Regulatory Audit program
• Supports GEHC Health / Competent Authority audits
• Advises management in Central Quality
• Uses high level of judgment to make decisions and handle complex tasks or problems
• Develops self and others by promoting strong Quality & Regulatory practices

Requirements

• Qualified Lead Auditor with active certification
• Master’s Degree and a minimum of 5 years’ experience in the medical device industry; or Bachelor's Degree and a minimum of 10 years’ experience in the medical device industry; or will consider a High School Diploma and a minimum of 15 years' of progressive responsibility in the medical device industry
• Minimum of 5 years’ Experience driving Global programs to resolve quality compliance issues (directly)
• Experience with Medical Device QMS requirements and regulatory requirements including FDA CFR 21 820 and ISO 13485
• Prior notified body or health authority experience a plus
• ASQ Certification (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt)
• Understanding of product quality improvement using tools such as Six Sigma, DFR

Benefits

• Health insurance
• 401(k) plan with employee and company contribution opportunities
• Paid time off
• Life insurance
• Disability insurance
• Accident insurance
• Tuition reimbursement