Greiner Bio-One Americas · 3 weeks ago
Senior Quality Systems Manager
Monroe, NC
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expGreiner Bio-One Americas is a company focused on quality management in the medical device industry. They are seeking a Senior Quality Systems Manager to oversee the quality management system (QMS), ensuring compliance with regulatory standards and improving process efficiency.
Biotechnology
Responsibilities
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
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
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
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)
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
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
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
8+ years of experience in the medical device industry with at least 5 years in a leadership role
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
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
Preferred
advanced degree preferred
Experience with implementation MasterControl preferred
Certifications such as Certified Manager of Quality/Organizational Excellence (CMQ/OE) from ASQ, Six Sigma Black Belt, or similar are highly desirable
Company
Greiner Bio-One Americas
Greiner Bio-One specializes in the development, production and distribution of high-quality plastic laboratory products.
1001-5000 employees
H1B Sponsorship
Greiner Bio-One Americas has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (1)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Michael Johnson
Human Resources Business Partner
Recent News
2025-07-04
2025-06-26
Company data provided by crunchbase