Senior Auditor, Quality System Compliance & Audit (Hybrid - Acton, MA)
Insulet(3 months ago)
About this role
A Senior Auditor, Quality System Compliance & Audit at Insulet is an experienced internal quality professional within the global Quality Systems organization, reporting to the Director of Quality Systems Compliance & Audit. The role supports regulatory compliance and quality system oversight in the medical device sector and requires 5–7 years of QA or Regulatory Affairs experience.
Required Skills
- Internal Audit
- External Audit
- CAPA Management
- Root Cause
- ISO 13485
- EU MDR
- FDA Inspections
- QMS Evaluation
- eQMS
- SharePoint
+3 more
Qualifications
- Bachelor's Degree
- ISO 13485 Lead Auditor
- Certified Quality Auditor (CQA)
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