Description
Description
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
1. Audits areas of the vascular quality system, such as development and manufacturing, as assigned.;
2. Creates audit checklists based on assigned area, applicable regulations, and pertinent 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. Oversees follow-up of corrective actions and audit closure, including escalating overdue items as necessary.;
11. Serves as escort to inspectors or assessors from regulatory agencies or notified bodies.;
12. Provides input to Regulatory Compliance Manager on audit staff performance.;
13. As requested, coordinates product actions (for example recalls) with manufacturing units and affiliates.;
14. As requested, communicates product actions and subsequent updates to regulatory bodies.;
15. Serves as quality system expert resource to management and to other business units as requested.;
16. Presents results of audits to senior management such as during periodic quality system reviews.;
17. Serves as point-of-contact for regulatory agency inspections or assessments.;
18. Works with Regulatory Compliance Manager to develop the annual audit schedule, assignments, and budgetary impact.;
19. Provides input to Regulatory Compliance Manager regarding Lead Auditor performance.
Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.
Comment:
Candidates should have at least 10 years experience and some MUST be with MEDICAL DEVICES. Must have experience with European Medical Device Directives; Canadian Regulations; Internal and External Audits. Looking for CERTIFIED AUDITORS.
SKILLS
NA
Synectics is an Equal Opportunity Employer.