
Lead Auditor
Plan device internal audits and external suppliers/contract manufacturers by preparing and communicating detailed audit plans and audit criteria. Support supplier audits of device and combination product suppliers as necessary. Execute audits through the evaluation of operations/processes, the review of documents and records, and interviews of employees for compliance. Communicate audit results through the preparation and publication of audit reports. Follow-up on audit results by seeking appropriate corrective and preventive actions if deficiencies are noted. Tracks consistent and accurate implementation of CAPA and verifies that actions taken are effective. Supports management with the tracking of internal and external audit activities and administration of audit schedule. Support external audits including interfacing with regulatory agencies, registrars, corporate and customers if necessary. Lead and support projects and initiatives to achieve Quality Systems objectives and any other regulatory objectives (e.g., QSR training, Quality Systems improvement initiatives, etc). Demonstrates a commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
5+ years’ experience is required
Current Medical Device Lead Auditor credentials and documented training on US FDA Medical Device Regulation training
Expert understanding of ISO 19011
10+ years of progressive experience lead device auditor for products marketed in the US, Europe, China, Japan, Canada a plus
Documentation
Time Management
Data analysis skills
Interfacing with regulatory agencies
Process Improvement
Self directed
Communication Skills
Adaptability
Multi-tasker
According to JobzMall, the average salary range for a Lead Auditor in 7000 Portage Rd, Kalamazoo, MI 49001, USA is between $52,000 and $73,000 per year. This range may vary based on experience, the type of organization, and the size of the organization.
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Pfizer Inc. is an American multinational pharmaceutical corporation headquartered in New York City, with its research headquarters in Groton, Connecticut. It is one of the world's largest pharmaceutical companies.

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