Supplier Quality Specialist

Responsibilities

• Develop applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies.
• Serve as Supplier Quality associate for local and/or site-related suppliers (products and services).
• Support identification suppliers and collaborate with cross-functional and/or WW team to complete supplier selection process.
• Implement supplier approval strategy. Facilitate, manage, and track supplier qualification and approval progress.
• Support Supplier creation/updates in Aravo.
• Manage and maintain Quality Agreements with suppliers, when needed.
• Provide on-going Supplier Quality Assurance support to all existing local and site-related suppliers.
• Collect and archive all relevant Supplier-related documentation.
• Support Supplier Quality performance monitoring.
• Support and/or conduct supplier quality audits / assessments, as needed.
• Manage changes initiated by suppliers. Coordinate with appropriate cross-functional teams.
• Support QA/QC lab with supplier activities related to product batch release and customer complaints as necessary.
• Lead or support problem-solving and root cause analysis activities (CAPA, Audits, Nonconformances, customer complaints, Supplier related complaints, etc.), as needed.
• Support internal and external audits as a subject matter expert, and support pre-and post-audit activities, as needed.
• Track trends of various quality data sources. Analyze and report on metrics.
• Support Site and WW Quality continuous improvement initiatives.

Qualifications

Education: Bachelor's degree in a related field such as Quality Management, Engineering, or Business Administration.

Experience: Minimum of 5 years of experience in supplier quality management, preferably in a medical devices or pharmaceutical industry.

Skills: Strong knowledge of ISO standards, supplier management systems, and quality assurance processes. Proficiency in Microsoft Office Suite and Aravo.