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Quality Assurance Executive

2 months ago

Connecticut, United States X4 Life Sciences Full time

Quality Assurance Director

X4 Life Sciences is committed to enhancing patient outcomes through cutting-edge technology and exceptional products. As the Director of Quality Assurance, you will play a crucial role in maintaining the integrity, safety, and regulatory adherence of diagnostic and software-based medical devices. You will lead the Quality Assurance (QA) team, driving initiatives for ongoing enhancement and ensuring that our products consistently meet both internal and external regulatory benchmarks. This is a significant leadership position, where collaboration with departments such as R&D, Regulatory Affairs, Manufacturing, and others is essential to bring innovative medical devices to market.

Key Responsibilities:

  • Manage QA Operations: Oversee all facets of the quality assurance process, including the establishment and upkeep of Quality Management Systems (QMS) that comply with FDA, ISO, and global standards.
  • Ensure Compliance with Regulations: Confirm that all products adhere to pertinent regulatory requirements, including FDA (21 CFR Part 820 and 11), ISO 13485, ISO 14971, and international regulations such as EU MDR/IVDR.
  • Oversee Product Lifecycle: Navigate products through every stage of their lifecycle, from initial design and development to regulatory approval and continuous post-market assessment.
  • Lead and Develop Team: Mentor the QA team, fostering a culture of continuous improvement and high-quality standards.
  • Collaborative Leadership: Work closely with R&D, Regulatory Affairs, Manufacturing, and other critical teams to ensure comprehensive product quality and compliance.
  • Risk Management Oversight: Direct the risk management process in accordance with ISO 14971, ensuring that risks are systematically identified and mitigated.

Qualifications:

  • Experience: A minimum of 10 years in Quality Assurance within the medical device sector, with a focus on diagnostics and software-integrated products.
  • Regulatory Knowledge: Extensive understanding of FDA regulations, ISO standards, and international regulatory frameworks.
  • Leadership Capabilities: Demonstrated ability to lead and nurture QA teams, with a history of implementing continuous improvement strategies.
  • Educational Background: Bachelor's or Master's degree in Engineering, Life Sciences, or a related discipline. Advanced certifications in Quality Assurance or Regulatory Affairs are highly preferred.
  • Skill Set: Outstanding communication and leadership abilities, with a proven capacity to thrive in a dynamic, collaborative work environment.