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
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Collaborate with Quality, Purchasing, Engineering, and Manufacturing teams to resolve nonconforming material reports.
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Track, trend, and analyze nonconforming materials to ensure quality processes remain in control.
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Conduct failure mode analysis, root cause analysis, and other statistical evaluations for nonconforming materials.
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Review nonconforming material reports, address discrepancies, and escalate issues to management as needed.
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Prepare for and participate in material review board meetings, including acting as a backup Quality representative.
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Ensure proper management and status updates of nonconforming parts in SAP and on-site quarantine areas.
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Develop, implement, and maintain Quality Assurance procedures, standards, and controls.
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Support investigations of nonconformances and assist with corrective and preventive actions.
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Perform internal and external audits, including supplier audits, and assist with site audit support.
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Manage documentation and provide support for additional Quality System functions as needed.
Minimum Requirements
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Associates degree with 3+ years' experience managing complaints and investigations with metrics in pharma/medical device industry - OR - Bachelor’s Degree with 1+ years
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Knowledge of FDA CFR 820 and ISO 13485 requirements medical device manufacturing
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High level of motivation; ability to work independently.
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Ability to communicate well, both verbally and written
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Collaborative with strong levels of engagement with individuals and as a team member
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Participation experience with internal, external and supplier audits
Preferences:
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3+ years working in medical device industry
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Strong Statistical background
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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.
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What We Do
At Mallinckrodt, we use strategic vision and employee-driven momentum to pursue a powerful mission: Listening for needs and delivering solutions.
As a leader in specialty pharmaceuticals, we develop, manufacture, market and distribute innovative treatments for underserved patient populations within neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. . Our expertise also extends into acute and critical care hospital products, as well as our broad portfolio of generic prescription medicines and active pharmaceutical ingredients.
Together, we’re helping shape the future of the specialty pharmaceuticals industry by leveraging the values our founders instilled over 155 years ago – quality, integrity and service.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Equal Opportunity Employer
Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
