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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 compliance of diagnostic and software-driven medical devices. You will spearhead the Quality Assurance (QA) team, advocating for initiatives that foster continuous improvement and ensuring our products consistently meet both internal and external regulatory standards. This is a vital leadership position, where collaboration with departments such as R&D, Regulatory Affairs, and Manufacturing is essential to successfully launch innovative medical devices.

Key Responsibilities:

  • Lead QA Operations: Manage 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.
  • Regulatory Compliance Assurance: Ensure that all products adhere to applicable regulatory requirements, including FDA (21 CFR Part 820 and 11), ISO 13485, ISO 14971, and international regulations like EU MDR/IVDR.
  • Product Lifecycle Management: Oversee products through every stage of their lifecycle, from initial design and development to regulatory approval and ongoing post-market assessment.
  • Team Development: Guide and mentor the QA team, fostering a culture of continuous improvement and high-quality standards.
  • Collaborative Engagement: Work closely with R&D, Regulatory Affairs, Manufacturing, and other key teams to ensure comprehensive product quality and compliance.
  • Risk Management Oversight: Manage the risk management process in accordance with ISO 14971, ensuring systematic identification and mitigation of risks.

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 Experience: Demonstrated ability to lead and develop QA teams, with a proven history of implementing continuous improvement initiatives.
  • 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 valued.
  • Skill Set: Outstanding communication and leadership abilities, with a capacity to thrive in a dynamic, collaborative work environment.