Director of Quality Assurance

1 week ago

Boston, United States DSJ Global Full time

Job Summary:

The Quality Assurance Director will lead and oversee the quality assurance (QA) function for our medical device manufacturing operations across 7 plants. This role ensures compliance with regulatory requirements, drives continuous improvement in quality processes, and upholds the highest standards for product safety and efficacy. The Quality Assurance Director will develop and implement strategic quality initiatives, manage a team of QA professionals, and work closely with cross-functional teams to achieve company objectives.


Key Responsibilities:

  • Leadership & Strategy:
  • Develop and execute a comprehensive quality assurance strategy that aligns with corporate goals and regulatory requirements for all 7 manufacturing plants.
  • Provide leadership and mentorship to the QA team, including managers and staff at each plant, fostering a culture of continuous improvement and compliance.
  • Act as a key member of the senior leadership team, advising on quality-related issues and ensuring alignment with company objectives.
  • Regulatory Compliance:
  • Ensure compliance with applicable regulations, including FDA, ISO 13485, CE Mark, and other global medical device standards.
  • Lead internal and external audits, including those conducted by regulatory bodies, and ensure timely resolution of audit findings.
  • Stay current with industry regulations, standards, and best practices, ensuring that all manufacturing facilities remain compliant.
  • Quality Systems Management:
  • Oversee the development, implementation, and maintenance of Quality Management Systems (QMS) across all plants, ensuring consistency and adherence to standards.
  • Implement and monitor key quality metrics, such as non-conformance rates, CAPAs, complaint handling, and product release criteria.
  • Ensure proper documentation, validation, and verification processes are followed throughout the product lifecycle.
  • Continuous Improvement:
  • Drive process improvement initiatives to enhance product quality, reduce defects, and improve overall manufacturing efficiency.
  • Collaborate with manufacturing, engineering, and R&D teams to implement quality by design principles and improve design transfer processes.
  • Lead root cause analysis and problem-solving efforts for quality-related issues across the plants, ensuring effective corrective and preventive actions (CAPA).
  • Team Management:
  • Manage, mentor, and develop a team of QA managers and specialists at each plant, ensuring alignment with the overall quality strategy.
  • Provide training and development opportunities for team members to enhance their skills and knowledge in quality assurance and regulatory compliance.
  • Foster a culture of accountability, teamwork, and continuous learning within the QA team.
  • Stakeholder Collaboration:
  • Work closely with operations, supply chain, and engineering teams to ensure quality standards are integrated into production processes.
  • Serve as the primary point of contact for quality-related matters with customers, suppliers, and regulatory agencies.
  • Participate in cross-functional meetings to review quality performance, product launches, and changes to manufacturing processes.


Qualifications:

  • Bachelor’s degree in Engineering, Quality Management, Life Sciences, or a related field (Master’s degree preferred).
  • 10+ years of experience in quality assurance within the medical device industry, with at least 5 years in a leadership role.
  • Proven experience managing quality functions across multiple manufacturing sites.
  • Strong knowledge of FDA regulations, ISO 13485, CE Mark, and other relevant standards.
  • Demonstrated success in leading audits, managing CAPAs, and driving continuous improvement initiatives.
  • Excellent communication, leadership, and project management skills.
  • Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar certification preferred.

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