NCQA Quality & Accreditation Specialist managing NCQA standard areas for healthcare accreditation. Serving as project management lead and ensuring high - quality performance in accreditation processes.
About the role
- Senior Manager Quality Engineering Excellence at QuidelOrtho driving compliance and quality engineering across global manufacturing. Leading quality teams and ensuring alignment with regulatory standards.
Responsibilities
- 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
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