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Senior Quality Manager The Senior Manager, Quality Engineering provides strategic and operational leadership for Quality Systems and Quality Engineering activities supporting the Micro Reagents manufacturing operations in Sparks, MD. This role is responsible for ensuring compliance with

FDA, ISO

13485, and MDSAP requirements while driving continuous improvement, audit readiness, and Quality Management System effectiveness across the organization.

As a key member of the leadership team, this position partners closely with Manufacturing, Engineering, Regulatory Affairs, and Operations leaders to establish quality strategies, support business objectives, develop talent, and maintain a culture of quality and compliance. The Senior Manager, Quality Engineering plays a critical role in advancing operational excellence and ensuring the delivery of safe, effective, and compliant productsKey ResponsibilitiesQuality Systems & Compliance Leadership

• Lead Quality Systems and Quality Engineering activities supporting the Micro Reagents manufacturing operations.
• Develop, implement, and maintain Quality Management System (QMS) procedures, policies, and standards in compliance with regulatory and corporate requirements.
• Ensure compliance with FDA Quality Management System Regulation (QMSR), ISO 13485:2016, MDSAP, and other applicable regulations and standards.
• Provide interpretation and guidance on company-wide quality policies and procedures.
• Maintain appropriate quality oversight of all Quality Management System processes to support a continuous state of compliance.
• Support and strengthen site audit readiness through proactive quality system management and monitoring.

Audit, CAPA & Regulatory Support

• Lead and support internal, external, customer, corporate, and regulatory audits and inspections.
• Ensure effective execution and continuous improvement of Corrective and Preventive Action (CAPA) processes.
• Partner with cross-functional teams to address quality and compliance risks and implement sustainable solutions.
• Support new product development and product enhancement activities by providing quality engineering guidance and oversight.

Strategic & Operational Leadership

• Partner with site leadership to establish and quality objectives aligned with business priorities and key performance drivers.
• Develop and manage departmental budgets, schedules, performance metrics, and resource plans.
• Establish operational goals and ensure successful execution of strategic initiatives and quality improvement programs.
• Analyze performance trends and identify opportunities to improve efficiency, compliance, and overall quality system effectiveness.
• Contribute to the development and execution of quality and business strategies.

People Leadership & Talent Development

• Lead, coach, and develop Quality Engineering managers and professionals.
• Build organizational capability by identifying, developing, and mentoring high-potential talent.
• Foster a culture of accountability, collaboration, continuous learning, and operational excellence.
• Support succession planning and strengthen leadership bench strength across the organization.
• Delegate responsibilities appropriately while empowering team members to achieve results and grow professionally.

Cross-Functional Collaboration

• Collaborate effectively with senior leaders and stakeholders across quality, manufacturing, engineering, operations, and regulatory functions.
• Influence decision-making and drive alignment on quality initiatives across the business.
• Facilitate resolution of complex issues while maintaining strong working relationships and a customer-focused mindset.
• Participate on site and enterprise leadership teams and represent Quality in key business discussions.

Required Qualifications