Director, Field Actions – Reporting
QuidelOrtho
full-time
Posted on:
Location Type: Office
Location: Raritan • California • Florida • United States
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Salary
💰 $179,000 - $232,000 per year
Job Level
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 Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency
- Partner with Operations, R&D, Regulatory Affairs, Global Service Organization, Commercial 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
- Perform other work-related duties as assigned.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required
- 12+ 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.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- 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
Quality Management System (QMS)ISO 13485FDA 21 CFR 820IVDRdata analyticsroot cause analysisprocess excellenceregulatory complianceperformance metricsbudget management
Soft Skills
leadershipteam developmentcollaborationcommunicationinfluenceanalytical skillsproblem-solvingcontinuous improvementcoachingmentoring