The Director, Quality Engineering, provides strategic leadership and functional oversight for the Quality Engineering organization, ensuring quality strategy, regulatory compliance, product realization, and continuous improvement priorities are aligned with business objectives. This role builds organizational capability, drives cross-functional execution, and establishes systems and standards that support safe, effective, compliant products and organizational excellence.
Quality & Regulatory Strategy: Establish and oversee Quality Engineering strategy to ensure sustained compliance with FDA, ISO 13485, MDSAP, EU MDR, and internal QMS requirements; maintain inspection readiness, certification compliance, and proactive risk management
Organizational Leadership: Lead, develop, and scale the Quality Engineering function; set clear objectives, build leadership capability, allocate resources, and ensure team priorities align with enterprise and operational goals.
Product Realization Governance: Provide executive-level oversight of design controls, risk management, verification/validation, process validation, GD&T, inspection strategy, and statistical quality requirements across design transfer and manufacturing lifecycle activities.
CAPA & Quality System Effectiveness: Direct systemic root cause analysis, corrective and preventive action strategy, and cross-functional remediation efforts to eliminate recurring quality issues and strengthen QMS effectiveness.
Complaints, Nonconformance & Risk Escalation: Oversee complaint, nonconformance, containment, disposition, and escalation processes; ensure timely resolution, appropriate risk-based decision-making, and alignment with regulatory and business expectations.
Quality Metrics & Governance: Define, monitor, and communicate Quality Engineering performance metrics, trends, and risk indicators; support Management Review, Quality Governance, and leadership decision-making.
Audit & Inspection Leadership: Serve as a senior Quality Engineering leader during internal audits, external audits, notified body assessments, and regulatory inspections; represent the function with credibility and sound judgment.
Cross-Functional Influence: Partner with Operations, R&D, Regulatory Affairs, Clinical, Supply Chain, and executive stakeholders to resolve complex issues, improve quality outcomes, and align quality priorities with business needs.
Education:
- Bachelor’s Degree in Science from an accredited institution required; Master’s Degree preferred
Experience:
- Minimum of 12 years of progressive quality, engineering, manufacturing, or regulatory experience, preferably in orthopedic or other medical device environment
- Demonstrated ability to establish, lead, and improve Quality System processes, including governance mechanisms that measure effectiveness and drive sustained compliance.
- Minimum of 8 years of leadership experience in Quality Engineering, Quality Assurance, or a related medical device function, including experience leading managers, technical teams, or cross-functional quality initiatives.
- Advanced knowledge of inspection strategy, specification development, statistical techniques, gage R&R, GD&T applications, process validation, and risk-based quality decision-making.
- Significant experience representing Quality Engineering during FDA inspections, notified body audits, customer audits, and senior-level quality governance forums.
Functional/Technical Knowledge, Skills and Abilities Required:
- Executive-level verbal, written, presentation, and leadership communication skills, with the ability to influence decisions and communicate risk clearly across all levels of the organization.
- Strong business acumen and ability to partner effectively with Operations, R&D, Regulatory Affairs, Clinical, Supply Chain, Commercial, and executive leadership to align quality priorities with business objectives.
