Senior Manager, Quality Engineering

Role Overview

• Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives
• Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs
• Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements
• Drive harmonization and standardization of Operational Quality Engineering processes, procedures, and tools across sites and functions to strengthen compliance and efficiency
• Implementation of standardized NC / CAPA processes to drive robust risk management, CAPA effectiveness and continuous improvement
• Ensure effective management of nonconformances, deviations, and rework activities using structured root cause analysis methodologies
• Assess and mitigate quality risks associated with process, equipment and material
• Ensure quality engineering support for manufacturing changes and compliant execution of change controls and validation activities
• Driving harmonized, efficient, validation strategies for equipment, process and facilities
• Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle
• Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS)
• Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits
• Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements
• Coach and mentor emerging Quality leaders and technical experts to build organizational capability and ensure robust succession planning
• Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders
• Manage departmental budget and resources effectively, identifying opportunities to drive cost efficiencies while maintaining compliance and quality standards
• Model QuidelOrtho' s leadership principles by demonstrating collaboration, accountability, inclusion, and service mindset in all interactions
• Perform other work-related duties as assigned.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required
• 8+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership
• Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR
• Proven ability to lead and develop high-performing teams and build future technical and people leaders
• Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations
• Excellent collaboration, influence, and communication skills across functional and organizational boundaries
• Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement
• Experience leading in a matrixed, global organization and managing competing priorities effectively
• Commitment to scientific integrity, compliance excellence, and continuous improvement
• Willingness and ability to travel approximately 10–15%.

Benefits

• medical, dental, vision, life, and disability insurance
• 401(k) plan
• employee assistance program
• Employee Stock Purchase Plan
• paid time off (including sick time)
• paid Holidays