Manager of Quality Systems
The Manager of Quality Systems is responsible for overseeing and maintaining the effectiveness of the site’s Quality Management System in alignment with Sartorius standards and applicable regulatory requirements. This role ensures systematic management and analysis of customer complaints, driving structured problem-solving and continuous improvement initiatives. The position leads the definition, monitoring, and review of key performance indicators (KPIs), facilitating KPI-driven meetings to reinforce a quality-focused culture, improve processes, and measure performance outcomes. Additionally, the role is accountable for the oversight of equipment and instrument calibration programs to ensure accuracy, compliance, and operational reliability. The Manager of Quality Systems also serves as the primary lead for customer audits, ensuring readiness, coordination, and effective execution. This includes the management of audit outcomes through the implementation of corrective and preventive actions (CAPAs) to address findings and strengthen the overall quality system.
Grow with Us - Your Responsibilities
- Audit Management & Compliance
- Lead and oversee all customer, internal, and regulatory audits, ensuring full compliance with applicable standards and timely closure of findings.
- Maintain and continuously improve compliance with certifications including ISO 9001, ISO 13485, and RX-360.
- Customer Quality & Complaint Handling
- Ensure all customer observations and complaints are effectively communicated, assigned, and resolved within defined timelines.
- Drive robust root cause analysis and corrective actions to achieve timely complaint closure in accordance with company standards.
- Develop and implement strategies to achieve zero customer complaints and ensure closure adherence within 30 days.
- Quality Systems Oversight
- Own and manage core Quality System processes including CAPA, Nonconformance (NCPR), Change Control, and Document Control.
- Monitor system effectiveness through KPIs and metrics, driving continuous improvement initiatives.
- Ensure proper governance and lifecycle management of controlled documents.
- Leadership of Quality Functions
- Manage and develop the Document Control and Complaint Handling teams to ensure operational excellence and compliance.
- Foster a culture of quality, accountability, and continuou...
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