Advita Ortho
Director, Quality Engineering
2320 NW 66th Ct, Gainesville, FL 32653
On-site · Full-time
First seen by offpeak October 6, 2026
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Key Responsibilities
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 managementOrganizational 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.
Skills Knowledge and Expertise
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.
- 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.