Organize and facilitate the external supplier audit program by analyzing data, coordinating audit logistics, and ensuring documentation is completed per QMS requirements

Independently analyze supplier compliance against applicable requirements and determine or recommend appropriate audit findings and follow-up actions.

Act as auditor/lead auditor within the designated auditing team on supplier audits.

Develop strategic audit plans for suppliers selected for audit, referencing applicable procedures and aligning with Supplier Quality Engineering on audit scope.

Engineering on audit scope. Assess supplier changes and review previous audits and supplier performance.

Conduct audit activities in a professional manner. Review supplier procedures against internal and external compliance requirements. *

Author supplier audit reports following QMS requirements and provide a summary of the audit. Draw conclusions regarding compliance status and present potential findings for leadership review. Provide well-founded recommendations for improvement. Run closing meetings and review process for audit follow-up activities.

Evaluate the adequacy of supplier corrective-action responses and determine whether additional evidence, remediation, or escalation is required to ensure any nonconformances are sufficiently addressed.

Manage the development and maintenance of the supplier audit schedule in alignment with leadership and Supplier Quality Engineering to support ongoing quality improvement efforts and business objectives.

Lead the preparation, review, and update of Supplier Quality Agreements by developing criteria, ensuring alignment with regulatory standards, and collaborating with suppliers to address quality issues.

Maintain the Approved Distributor List (ADL)

Proactively identify and collaborate with suppliers to resolve day-to-day quality and compliance issues and address potential issues before they escalate.

Senior Supplier Quality & Compliance Analyst

Responsibilities

Benefits

Company

Penumbrainc

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