New

Quality Coordinator

Mallinckrodt Pharmaceuticals
United States, Wisconsin, Madison
6603 Femrite Drive (Show on map)
Nov 25, 2024
Job Title Quality Coordinator Requisition JR000014663 Quality Coordinator (Open) Location Madison, WI Additional Locations Job Description Summary Job Description The Quality Coordinator oversees the nonconforming material report process, including organizing material review board meetings and managing the status of quarantined and scrapped materials. The Quality Coordinator is responsible for tracking and analyzing nonconforming products to support site metrics and supplier quality assessments. The Quality Coordinator ensures all tasks align with current GMP standards and comply with established procedures to maintain the quality and integrity of the process. Essential Functions Collaborate with Quality, Purchasing, Engineering, and Manufacturing teams to resolve nonconforming material reports. Track, trend, and analyze nonconforming materials to ensure quality processes remain in control. Conduct failure mode analysis, root cause analysis, and other statistical evaluations for nonconforming materials. Review nonconforming material reports, address discrepancies, and escalate issues to management as needed. Prepare for and participate in material review board meetings, including acting as a backup Quality representative. Ensure proper management and status updates of nonconforming parts in SAP and on-site quarantine areas. Develop, implement, and maintain Quality Assurance procedures, standards, and controls. Support investigations of nonconformances and assist with corrective and preventive actions. Perform internal and external audits, including supplier audits, and assist with site audit support. Manage documentation and provide support for additional Quality System functions as needed. Minimum Requirements Associates degree with 3+ years' experience managing complaints and investigations with metrics in pharma/medical device industry - OR - Bachelor's Degree with 1+ years Knowledge of FDA CFR 820 and ISO 13485 requirements medical device manufacturing High level of motivation; ability to work independently. Ability to communicate well, both verbally and written Collaborative with strong levels of engagement with individuals and as a team member Participation experience with internal, external and supplier audits Preferences: 3+ years working in medical device industry Strong Statistical background Auditor Certification (ASQ CQA or CMDA) Organizational Relationship/Scope: Reports to the Quality Control Manager. This position is accountable for delivery of prompt investigative work and detailed reporting. Working across multiple functions, this position collaborates primarily with manufacturing, engineering and quality to assess nonconforming products and support supplier quality issues. Working Conditions: Manufacturing facility of medical devices and accessories. Controlled environmental working conditions. #LI-LM1