Supplier quality officer

Keep AM (Auditee Information Management) records updated with any information related to

materials, supplier qualification and monitoring activities.

⁃ Support any supplier data alignment within the SQ AM records and Local systems (e.g.

SAP/Panda/Atlas).

⁃ Supportive actions associated with Remote Audits - Quality Questionnaires evaluation

⁃ Open/Manage Audit records when requested.

⁃ Support completion of J&J Quality Requirements/Quality Agreements with suppliers.

⁃ Support the Approved Supplier List (ASL) review.

⁃ Coordinate completion of Specification agreements with suppliers.

⁃ Supportive actions associated with Change control and assessment.

⁃ Collaboration on project part of teamwork across EQ-SQ organization.

⁃ Provide supplier data for metrics and risk management documents.

⁃ Follow-up activities related to EQ-SQ

⁃ Should be able to write and review device or combination product Investigation and CAPA

report.

⁃ Management of Change related to supplier and/or external manufacturers (change assessor,

action executioner)

⁃ Supportive activities related to the Qualification of suppliers for new product introductions

⁃ Supportive activities to feed data for Periodic performance measurement of suppliers

⁃ Support communication between overseas team members and Japanese suppliers (including

translation between Japanese and English)