Senior Quality Systems Manager

Your challenge

Responsibility:
The Sr. Quality System Manager is responsible for overseeing the quality management system (QMS) to ensure compliance with regulatory standards, improve process efficiency, and maintain product quality. This role focuses on managing the electronic quality document system (eQMS), Corrective and Preventive Actions (CAPAs), change control processes, supplier and audit programs.
1.    Quality Management System Oversight
•    Manage and administer the Electronic Quality Management System (eQMS), ensuring all related documentation is compliant with applicable procedures and regulations
•    Chair Change Control and CAPA review boards, providing leadership in decision-making processes
•    Develop, implement, and maintain robust quality metrics to drive continuous improvement within the quality systems
•    Conduct trend analysis of nonconformances, deviations, and complaints to identify patterns requiring systemic solutions
•    Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and other applicable standards and regulations
2.    Corrective and Preventative Action (CAPA) Management
•    Manage the CAPA system to ensure appropriate investigation, implementation, closure, and effectiveness checks meet required timelines
•    Analyze root causes of quality issues and implement effective corrective and preventative actions
•    Track and trend CAPA data to identify systemic issues requiring organizational attention
•    Lead cross-functional teams to address complex CAPA investigations and implementations
3.    Change Control and Non-Conformance Management
•    Manage the change control system, coordinating the initiation, execution, and completion of changes
•    Track timely completion of change control commitments and manage extension requests
•    Oversee the non-conformance management process, ensuring timely execution, closure and resolution
4.    Audit Management

•    Manage audit planning, scheduling, and execute internal and external audits to assess compliance to the regulations. 
•    Audit external suppliers and maintain the vendor qualification program including the Approved Vendor Lis
•    Manage supplier corrective action request program (SCAR)

5.    Quality Data Analysis and Reporting
•    Establish, manage, and track quality system performance metrics to drive continuous improvement; Report to leadership, highlighting areas of concern and improvement opportunities
•    Conduct regular trend analysis across quality systems to identify proactive improvement initiatives
•    Prepare and present quality data for management review meetings
6.    Cross-Functional Collaboration and Leadership
•    Collaborate with cross-functional teams to drive quality initiatives and resolve quality issues
•    Lead interactions between different departments to ensure quality requirements are understood and implemented
•    Support and participate in external audits including FDA, customers, and corporate audits

Your Profile

Job Requirements:
•    Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.
•    8+ years of experience in the medical device industry with at least 5 years in a leadership role, with a strong background in QMS, CAPA, Supplier Management and Audits, and regulatory compliance (ISO 13485, 21 CFR 820).
•    Proven experience for implementation and maintenance of electronic Quality Management software. Experience with implementation MasterControl preferred.  
•    Demonstrated leadership and project management skills with a track record in quality system management.
•    Strong knowledge of FDA and ISO quality standards and the ability to lead regulatory compliance initiatives.
•    Certifications such as Certified Manager of Quality/Organizational Excellence (CMQ/OE) from ASQ, Six Sigma Black Belt, or similar are highly desirable.