Senior Quality Assurance Director

5 days ago


Dedham, Massachusetts, United States Michael Page Full time
About the Role

This is a leadership opportunity to drive quality initiatives across the organization, overseeing QA and QC teams, and ensuring product quality.

Key Responsibilities
  • Develop and implement quality systems aligned with regulatory requirements.
  • Manage CAPA, NCMR, audits, and complaints processes.
  • C Coordinate global QMS processes to ensure consistency across multiple sites.
  • Support new product development with compliance in requirements, specifications, and test protocols.
  • Oversight of product and process changes to ensure risk management and regulatory compliance.
  • Act as the QMS expert, staying updated on regulatory changes and industry standards.
Requirements
  • Expert in ISO 13485, ISO 9001, FDA QSR, IVDR, and safety standards.
  • 10+ years of quality systems experience in medical devices and in vitro diagnostics (IVD).
  • 5+ years of leadership in team management and performance development.
  • Proven success in managing ISO/MDSAP audits and regulatory inspections.
  • Proficient in electronic QMS platforms and data-driven tools.
  • Strong communicator with exceptional organizational skills.
What You Will Gain
  • Leadership Role: Directly manage and lead Quality Assurance (QA) and Quality Control (QC) teams.
  • Strategic Impact: Lead and enhance the Quality Management System (QMS), including CAPA, audits, and compliance processes.
  • Global Exposure: Coordinate and align QMS activities with global teams, offering the chance to work across multiple sites.
  • Innovation and Development: Play a key role in new product development, ensuring regulatory compliance and quality throughout the process.
  • Continuous Improvement: Foster a strong culture of quality and continuous improvement.

Estimated salary range for this position is $120,000 - $180,000 per year, depending on location and experience. Michael Page is an equal opportunities employer.


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