Staff Auditor, Quality System Compliance & Audit (Hybrid - Acton, MA)
Insulet(2 months ago)
About this role
Staff Internal Quality Auditor at a medical device company responsible for ensuring the integrity and Quality Management System (QMS) and driving continuous improvement across global sites. The role partners with regulatory and cross-functional teams to support internal and external audits, inspections, and compliance with international standards. It reports to the Director of Quality Systems Compliance & Audit and focuses on audit program ownership, risk-based quality initiatives, and executive-level reporting.
Required Skills
- Internal Auditing
- External Auditing
- Regulatory Compliance
- CAPA
- Risk Management
- Audit Planning
- Audit Reporting
- Root Cause
- Data Analysis
- Training
+4 more
Qualifications
- Bachelor's Degree in Engineering or Life Sciences
- Advanced Degree (Preferred)
- CQA
- CMDA
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