Senior Quality Manager

Senior Manager, Quality Engineering

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 products.

Key Responsibilities

• 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.

• 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.

• Partner with site leadership to establish and execute 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.

• 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.

• 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

• Bachelor's degree in Engineering, Science, Quality, or another related technical discipline.

• Minimum of 6-8 years of progressive leadership experience in Quality Engineering, Quality Systems, Regulatory Compliance, or a related function within a regulated industry.
• Experience managing Quality Management Systems within a manufacturing environment.
• Experience leading quality teams and driving organizational objectives through influence and collaboration.
• Experience managing departmental budgets, work plans, and performance goals.

• Strong knowledge of FDA Quality Management System Regulation (QMSR), ISO 13485:2016, and Medical Device Single Audit Program (MDSAP) requirements.
• Strong understanding of Quality Management Systems, quality engineering principles, and regulatory compliance.
• Proven ability to lead multiple priorities and execute strategic and operational objectives.
• Strong verbal and written communication skills with the ability to communicate effectively at all levels of the organization.
• Ability to build relationships, influence stakeholders, and drive results in a matrixed environment.
• Strong problem-solving, decision-making, and conflict-resolution skills.
• Experience developing and mentoring talent, including identifying and advancing high-potential associates.
• Demonstrated ability to lead teams through change while maintaining focus on business objectives and compliance requirements.
• Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.

Preferred Qualifications

• Medical device manufacturing experience.
• Experience supporting FDA inspections, notified body audits, or other regulatory assessments.
• Experience leading site-wide quality initiatives and quality system improvements.
• Lean Manufacturing, Operational Excellence, or Continuous Improvement experience.
• ASQ certification and/or advanced degree.