Director, Central Quality Audit
Location
United States
Posted
11 days ago
Salary
$142.4K - $213.6K / year
Job Description
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
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