Supplier Quality Assurance Specialist

2 weeks ago


Pleasant Prairie, Wisconsin, United States Medasource Full time

Position: Materials Management Quality Assurance Specialist

Company: Medasource

Location: Remote

Contract Duration: 12-24 months with potential extensions

Benefits: Health, Dental, Vision

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 reject materials or suppliers based on assessment outcomes.


• Conduct regular evaluations of supplier performance and take appropriate actions based on findings.


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


• Initiation and assessment of supplier questionnaires.


• Conducting quality audits in line with global standards.


• Initiation, review, and updates of Quality Agreements.


• Manage the Approved Supplier List, including updates and modifications.


• Oversee Supplier Quality Management activities within SAP and Trackwise.


• Provide insights and recommendations for Supplier and Service Provider approvals.


• Handle materials and supplier complaints effectively.


• Maintain a complaint database to track supplier responses.


• Represent quality perspectives in supplier committees to ensure compliance.


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


• Monitor and report on materials management metrics to relevant committees.


• Collaborate with global resources to ensure compliance with standards.

Minimum Qualifications:


• Bachelor's Degree or equivalent experience in a scientific discipline.


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


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


• Excellent verbal and written communication skills.


• Ability to influence suppliers and stakeholders across various sites.


• Strong technical writing capabilities.


• Experience in materials management, quality systems, and cGMPs.

Additional Information:


• Overtime may be necessary.


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


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



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