Supplier Quality Compliance Auditor

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Supplier Quality Compliance Auditor will be responsible for leading on-site and remote supplier audits and completing qualifications of new suppliers for global Kindeva. In addition, negotiate Supplier Quality Agreements, write Supplier Risk Assessments, review Supplier Material Safety Risk Questionnaires and fill out Material Safety Risk Summaries, maintain documentation for supplier oversight and summarize documentation for supplier scorecards and reassessments.

 Role Responsibilities

• Manage supplier qualification status in the Quality Tracking System (QTS) including entry of suppliers, creation of supplier channels, and completion of qualification tasks in QTS
• Maintain the Approved Supplier List and GMP Materials Supply Chain
• Lead on-site and remote quality audits for suppliers
• Assist with supplier audit schedule, agendas, reports, and CAPA requirements
• Work with suppliers for completion of Material Safety Risk Questionnaires
• Draft and execute quality agreements per procedures
• Maintain updated contact information for supplier contacts
• Develop colleagues on the use of quality systems as they pertain to Supplier Management
• Conduct investigations on behalf of Supplier Quality Management where needed
• Responsible person for site change controls applicable to Supplier Quality Management (where applicable)
• Work closely with the Procurement department and Quality Engineers on supplier issues
• Conduct yearly Quality Agreement and Technical Agreement Annual Product Records Review report.

 Basic Qualifications

• B.S. degree
• 2+ years in a Quality position within the pharmaceutical or medical device industry
• Must have working knowledge of 21CFR parts 210 & 211, 820

• Ability to travel 25% to perform supplier audits in US and International locations as needed.

Preferred Qualifications

• Working knowledge of ISO 13485 and ISO 1725

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