Director of Quality Assurance

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• Develop and execute quality strategies that align with product development, regulatory requirements, and business objectives.
• Build, mentor, and lead a high-performing quality team, managing recruitment, onboarding, performance, and professional growth.
• Act as Subject Matter Expert for quality systems, risk management, and design quality planning.
• Lead hazard analyses, FMEA, benefit-risk assessments, and risk governance processes per ISO 14971.
• Drive cross-functional collaboration with R&D, Manufacturing, Regulatory, and Service teams to ensure alignment of quality goals.
• Oversee sustaining quality engineering projects, validations, product transfers, change controls, and calibrations.
• Chair meetings to resolve quality issues, ensure accountability for CAPAs, and maintain audit readiness.
• Monitor and analyze quality metrics, identifying trends and implementing proactive improvements.
• Provide strategic input on evolving regulatory requirements (FDA, ISO, EU MDR, and international standards).
• Manage departmental budgets, resources, and efficiency initiatives to support organizational growth.
• Support business development through quality due diligence and integration activities.

• 8+ years of experience in medical device quality, including direct management experience.
• Strong knowledge of global regulatory requirements (ISO 13485, FDA QSR, EU MDR, and international standards).
• Experience with complaint handling, adverse event reporting, CAPA, and corrective action processes.
• Demonstrated leadership with proven ability to manage teams, set strategy, and deliver results.
• Strong technical knowledge of medical devices and design controls.
• Skilled in process improvement, trending/analysis reporting, and project management.
• Excellent communication, collaboration, and team-building skills.

• Director

• Full-time

• Quality Assurance and Project Management
• Industries:
  Biotechnology Research, Medical Equipment Manufacturing, and Hospitals and Health Care

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