Regulatory Compliance Auditor, Sr Job in Menlo Park 94025, California US
Title: Regulatory Compliance Auditor, Sr
Duration: 12+ Months Contract
Location: Menlo Park CA
DESCRIPTION:
1.Audits areas of the Abbott Vascular quality system, such as development and manufacturing, as assigned.;
2. Creates audit checklists based on assigned area, applicable regulations, and pertinent Abbott Vascular quality system/procedural requirements, and obtains approval from Lead Auditor as appropriate.;
3. Evaluates the adequacy and compliance of systems, operations, and practices against regulations and company documentation.;
4. Formulates and documents nonconformity and obtains concurrence with responsible management.;
5. Tracks issues through to closure including reviewing the corrective action taken.;
6. Develops an audit plan including scope and objective and obtains management approval.;
7. Provides work direction to audit team.;
8. Communicates final results of audits to responsible management during formal management debriefs.;
9. Writes reports of audit results, obtains approval, and publishes results to responsible management.;
10.Must have experience with European Medical Device Directives; Canadian Regulations; Internal and External Audits. CERTIFIED AUDITORS would be a PLUS.