Director of Quality Assurance

3 weeks ago

Burlington, United States BrightHire Search Partners Full time

Director of Quality Assurance

We are seeking a Director of Quality Assurance to lead the quality systems for a revolutionizing medical device company that is changing the world of imaging. This is an opportunity to plan, direct, implement, and maintain quality assurance standards to ensure the delivery of high-quality products.

Job Duties:

  • Serve as the QSR/ISO management representative
  • Work with the FDA, and California State Department of Health during company inspections
  • Certify adverse event fillings to foreign regulatory authorities are aligned with company policies and foreign regulatory requirements.
  • Hire, develop, and mentor a team of Quality Engineers
  • Work with cross-functional teams to ensure compliance is being met on all levels.
  • Implement and maintain compliance with QSR and ISO 13485
  • Develop and lead programs for best practices for compliance and quality assurance.
  • Design control activities and work with the design engineering team on risk management for new product features.
  • Develop and implement the Quality Department budget, schedules, objectives, training plans, and performance reviews.

Qualifications:

  • B.S. in life sciences, engineering, or equivalent experience required.
  • 5+ years of management experience
  • Experience working with an Electromechanical Medical Device
  • 10+ years of related experience in the Class II, and Class III medical device industry.
  • Proficient in 21CFR 820 and the Medical Device Directive
  • Solid knowledge of FDA Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP), and applicable Quality System Standards
  • Experience with ISO 62304, Medical Device Software - Software Life Cycle processes
  • Familiar with EN 60601, Safety requirements for medical electrical systems
  • ISO 13485 Lead Auditor training
  • Ability to analyze and interpret standards, technical procedures, professional journals, and governmental guidance and regulation documents.
  • Experience with manufacturing or product development is a huge plus
  • Direct interaction with FDA reviewers/inspectors
  • Working knowledge of MDR/ Vigilance Reporting

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