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Supplier Quality Assurance Specialist

2 months ago


Pleasant Prairie, Wisconsin, United States Medasource Full time

Position: Materials Management Quality Assurance Specialist

Client: Medasource

Contract Duration: 12-24 months with potential extensions

Benefits: Health, Dental, Vision coverage

Shift: Day Shift

Key Responsibilities:


• Develop and uphold the supplier quality management framework in collaboration with other manufacturing sites and global teams.


• Perform assessments and classifications of materials and supplier risks as necessary.


• Officially approve or decline materials or suppliers based on assessment outcomes.


• Conduct regular evaluations of supplier performance, formally approving or rejecting materials or suppliers based on review results.


• Ensure that initial and ongoing supplier quality management tasks are executed, including:


• Initiation and evaluation of supplier questionnaires.


• Conducting quality audits in alignment with global standards.


• Initiation, assessment, and updating of Quality Agreements.


• Oversee the management of the Approved Supplier List, including modifications and updates.


• Manage Supplier Quality Management activities within SAP and Trackwise.


• Provide insights and recommendations for the approval and certification of suppliers and service providers.


• Handle materials and supplier complaints effectively.


• Maintain a comprehensive complaint database to track supplier responses.


• Represent quality concerns in supplier committees, ensuring compliance.


• Assist in regulatory inspections by providing necessary documentation and subject matter expertise.


• Monitor and report on materials management metrics during supplier meetings and governance committees.


• Collaborate with global resources to ensure compliance with established requirements.

Minimum Qualifications:


• Bachelor’s Degree or equivalent experience in a science-related discipline.


• At least 2 years of relevant experience in a GMP environment.


• Proficient in current computer applications, including Microsoft Office, LMS, EDMS, and TrackWise.


• Excellent verbal and written communication skills.


• Ability to influence suppliers and stakeholders across various sites.


• Proven technical writing capabilities.


• Experience in materials management, quality systems, and cGMP practices.

Additional Information:


• Overtime may be necessary.


• Flexibility to address operational issues outside standard business hours may be required.


• Occasional travel may be involved (approximately 10%).