Senior Quality Systems Manager

Senior Quality Systems Manager

Join to apply for the Senior Quality Systems Manager role at Greiner Bio‑One Americas.

• Oversee the quality management system (QMS) to ensure compliance with regulatory standards, improve process efficiency, and maintain product quality.
• Manage and administer the Electronic Quality Management System (eQMS), ensuring all 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.
• 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 preventive actions.
• Track and trend CAPA data to identify systemic issues requiring organizational attention.
• Lead cross‑functional teams to address complex CAPA investigations and implementations.
• 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.
• Manage audit planning, scheduling, and execution of internal and external audits to assess compliance with regulations.
• Audit external suppliers and maintain the vendor qualification program including the Approved Vendor List.
• Manage the supplier corrective action request (SCAR) program.
• 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.
• 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.

• 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, Audits, and regulatory compliance (ISO 13485, 21 CFR 820).
• Proven experience in implementation and maintenance of electronic QMS software; experience with Master Control 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.

Mid‑Senior level

Full‑time

Quality Assurance

Medical Equipment Manufacturing

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants – regardless of characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.