QuidelOrtho

Senior Manager, Quality Engineering

QuidelOrtho

full-time

Posted on:

Location Type: Office

Location: Rochester • California • Florida • United States

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Salary

💰 $155,000 - $202,000 per year

Job Level

Senior

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
ISO 13485FDA 21 CFR 820IVDRQuality System regulationsroot cause analysisrisk managementCAPA processesdata analyticsvalidation strategiesQuality Management System (QMS)
Soft Skills
leadershipcollaborationcommunicationanalytical skillsproblem-solvinginfluencecontinuous improvementmentoringorganizational capabilitybudget management