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Responsibilities:

• The Principal Supplier Quality Auditor will be responsible for implementing best practice initiatives to improve process capability and will provide ongoing leadership and for ensuring that our product is manufactured within specification and in accordance with 21CFR Part 210, 211, 820 and ISO 13485 Quality Systems and GMP based Quality Systems requirements.
• Conduct supplier audits to maintain compliance to Cardinal Health Supplier Quality Audit Schedules and Processes.
• Work with suppliers to ensure corrective and preventive actions resulting from audit findings are completed in an effective and timely manner Work with Medical Solutions sites to ensure activities related to Supplier Management and Supplier Auditing are executed according to internal procedures and applicable regulations and standards. Examples include but are not limited to:
• Add/modify/obsolete site level suppliers to GASL following site level changes in Agile Work with sites to ensure supplier files are uploaded and compliant with corporate supplier management requirements Work with sites to ensure supplier annual review is executed and routed Assist Medical Solutions sites with internal corporate and external regulatory audits for any Supplier Quality related questions/ concerns during the audit Draft, manage and execute Supplier Quality agreements for shared suppliers as needed Collaborate with sites to offer guidance related to site level Supplier Change Requests & CDP's Work with sites to ensure Supplier Controls and Monitoring are adequate per internal processes as well as regulatory standards and requirements. (i.e.: Supplier Risk Mitigation Plan execution and Supplier Quality Plans) Attend monthly COE & Sourcing Meetings with insight and knowledge pertaining to the suppliers applicable to sites that you are directly responsible for working with
• Collaborate with team members to improve upon current supplier quality procedures and documents in an effort to streamline the supplier auditing program and the supplier management processes Assist in review and approval of global approved supplier list creation and maintenance Ensure supplier quality systems adhere to industry standards Manage corrective actions to assure effective corrective and preventative actions, to avoid repeat issues.
• Initiate and manage actions for supplier quality SCARs and CAPAs as needed. Issue Supplier Corrective Action extensions for sites that need additional time to execute actions related to the SCAR.
• Identify the true critical to quality procedures (CTQs) for each component and the critical to quality components within the supplier quality global approved supplier list Identify continuous improvements opportunities where possible and take part in improvement projects as assigned Adhere to GMP based Quality Systems requirements for medical devices and medicinal product (e.g. MDD, EU GMP Guidelines Vol IV Part 1 for medicinal product, ISO 13485).
• Actively participate in fulfilling Cardinal Health's initiative to increase awareness around Diversity & Inclusion within your core team Carry out additional duties that may be assigned to you.
• Experience of working within a regulated industry with knowledge of MDD (Medical Device Directive), ISO 13485 (Quality Management Systems), Pharmaceutical guidelines, FDA, cGMP, and Risk Management (ISO 14971)
• Knowledge of business platforms and processes Smart Solve, SAP, BPCS, Agile, DMRs/Formula Sheets, and Adobe Echo Sign Ability to work with or lead cross-functional teams, including production, quality, engineering and sourcing to understand respective impact of process changes or improvements.
• Ability to multi-task and to work in a high paced environment with an awareness of continued impact on production and the plant performance.
• Organized and resourceful with excellent attention to detail and ability to get the job done Clear written and verbal communication skills in English or native languages as needed The ability to take responsibility for their own professional development and implement new approaches to doing things.
• Commitment to work within the ethos of the company Mission, Medical Devices & Supplies Guide to Compliance and Quality Manufacturing and company code of conduct.

Requirement:

• Bachelors in related field, or equivalent work experience, preferred
• 4+ years' experience in related field, preferred
• AUDIT
• AUDITS
• BPCS
• CGMP
• FDA
• GMP
• ISO
• MEDICAL DEVICE
• MEDICAL DEVICES
• MITIGATION
• RISK MANAGEMENT
• SAP
• SUPPLIER AUDITS
• SUPPLIER QUALITY
• AUDITING
• CORRECTIVE ACTION
• EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS MAINTENANCE SUPPLIER MANAGEMENT TRADING
• Minimum Degree Required: Bachelor's Degree