Director, Central Quality Audit
Location
United States
Posted
20 hours ago
Salary
$142.4K - $213.6K / year
5 yrs expExperience acceptedEnglish
Job Description
• 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
Job 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
