Senior Specialist, Quality Systems Enterprise

The Senior Specialist, Quality Systems is a senior-level individual contributor responsible for end-to-end administration, governance, and continuous improvement of key elements of the Quality Management System (QMS), with primary accountability for post-market surveillance processes and eQMS functionality within Quest Diagnostics.

This role serves as a Subject Matter Expert (SME) in regulatory compliance and quality systems, ensuring alignment with FDA regulations, including 21 CFR Part 820, 21 CFR Part 803, ISO 13485, and ISO 14971. The position has significant influence on quality system design, inspection readiness, and cross-functional quality outcomes.

QMS Administration

• Serve as system administrator for SmartSolve modules supporting complaint handling, MDR evaluation, and recall management.
• Ensure system configuration, workflows, and data integrity meet regulatory and internal requirements.
• Lead system enhancements, change control, and validation activities (CSV) in alignment with regulatory expectations.

Post-Market Surveillance

• Oversee complaint handling processes in compliance with 21 CFR 820.198.
• Perform and/or approve MDR reportability assessments in accordance with 21 CFR Part 803.
• Lead and coordinate corrections and removals (recalls), including supplier-related events, per 21 CFR Part 806.
• Ensure complete, accurate, and inspection-ready documentation for all post-market activities.

Quality System Governance

• Manage SOP lifecycle (authoring, implementation, periodic review, and compliance monitoring).
• Ensure QA record management and retention practices meet regulatory and corporate requirements.
• Schedule and lead CHU team Quality meetings; track and drive closure of actions.

CAPA Integration & Effectiveness

• Interface with CAPA processes to ensure appropriate escalation and linkage to complaints and recalls.
• Conduct effectiveness checks and ongoing monitoring of corrective and preventive actions.
• Drive systemic improvements based on root cause analysis and trending.

Data Analytics & Continuous Improvement

• Own quality metrics related to complaints, MDRs, recalls and others as determined
• Analyze and trend data to identify systemic risks and opportunities for improvement.
• Lead initiatives to reduce cost of poor quality (COPQ, Cost of a Complaint) and improve overall QMS performance.

Additional Responsibilities

• Lead or support cross-functional quality initiatives and special projects.
• Perform other duties as assigned.

Required WorkExperience:

• Minimum 8+ years of experience in Quality Systems, Quality Assurance, Manufacturing Quality, or Regulatory Affairs within a regulated industry (medical device, diagnostics, or healthcare).
• Demonstrated experience with Quality Management Systems (QMS), including process ownership, governance, and continuous improvement.
• Hands-on experience with post-market surveillance processes, including complaint handling, MDR reporting, CAPA, and recall/corrections & removals.
• Experience working with electronic QMS platforms (eQMS)such as SmartSolve or similar systems.
• Proven experience supporting regulatory audits/inspections (FDA, ISO) and ensuring compliance with 21 CFR Part 820 and ISO 13485.
• Demonstrated experience operating at an independent contributor / SME level.
• Excellent analytical and problem-solving skills.
• Demonstrates technical leadership without direct authority.
• Strong communication and interpersonal skills to effectively interact with internal and external customers.

Preferred Work Experience:

• 10-15+ years of experience in Quality Systems or related functions within medical device, IVD, or diagnostics organizations, preferably in a multi-site or global environment.
• Direct experience leading or supporting eQMS implementations or enhancements (e.g., SmartSolve complaint module or similar systems).
• Experience managing or contributing to enterprise-level QMS transformation initiatives or large-scale process improvements.
• Demonstrated leadership in cross-functional project management, including use of structured methodologies (e.g., Stage Gate, PMP frameworks).
• Experience applying Lean Six Sigma principles(Green Belt, Black Belt preferred) to drive measurable quality and operational improvements.

Physical and Mental Requirements:

• Ability to sit for extended periods and work extensively on a computer reviewing data, documentation, and quality records.
• Ability to analyze complex technical, regulatory, and quality information with strong attention to detail.
• Capability to manage multiple priorities and deadlines in a fast-paced, highly regulated environment.
• Occasional ability to travel (if required) for audits, inspections, or cross-site collaboration.

Knowledge:

• FDA 21 CFR Part 820.198. Part 803, Part 806. ISO13485, 14971 requirements including MDSAP and EU MDR Post Market Regulations
• Lean, Six Sigma, Value Stream Mapping, Kaizen, Cost of Quality
• Excel (Pivot Tables), SQL, reporting tools and enterprise systems
• Experience with eQMS systems, preferably SmartSolve.
• Experience with quality systems; Complaint Handling, MDR reporting, CAPA, Non-Conformance, Change Control

Skills:

• Project Leadership: Strong ability to lead complex, cross-functional initiatives and drive results across multiple stakeholders
• Analytical & Problem-Solving: Expertise in root cause analysis, data trending, and risk-based decision making
• Regulatory Interpretation: Ability to interpret and apply FDA and ISO requirements to practical business processes
• Communication & Influence: Effective verbal and written communication; ability to influence without direct authority
• Process Improvement: Demonstrated ability to identify inefficiencies and implement sustainable improvements
• Attention to Detail: High level of accuracy in documentation, compliance, and data analysis
• Collaboration: Strong interpersonal skills with experience working across Quality, Engineering, Operations, IT, and external partners
• Organizational & Time Management: Ability to manage multiple projects and priorities simultaneously

Education:

• Bachelor's degree (required)
• Bachelor's degree in a scientific field, i.e. engineering (Preferred)
• Lean Six Sigma, Project Management (Preferred)