Quality Assurance Executive

2 weeks 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 safeguarding the integrity, safety, and compliance of diagnostic and software-based medical devices. You will lead the Quality Assurance (QA) division, driving initiatives for ongoing enhancement and ensuring that our offerings consistently meet both internal and external regulatory benchmarks. This pivotal leadership position requires collaboration with various departments, including R&D, Regulatory Affairs, and Manufacturing, to successfully launch innovative medical devices.

Key Responsibilities:

  • Manage QA Operations: Oversee all facets of the quality assurance framework, including the establishment and upkeep of Quality Management Systems (QMS) that comply with FDA, ISO, and international standards.
  • Ensure Compliance with Regulations: Confirm that all products adhere to pertinent regulatory guidelines, including FDA (21 CFR Part 820 and 11), ISO 13485, ISO 14971, and global regulations such as EU MDR/IVDR.
  • Oversee Product Lifecycle: Navigate products through each stage of their lifecycle, from initial design and development to regulatory endorsement and continuous post-market assessment.
  • Leadership and Mentorship: Direct and guide the QA team, fostering a culture of ongoing improvement and maintaining high-quality standards.
  • Collaborative Engagement: Work closely with R&D, Regulatory Affairs, Manufacturing, and other essential teams to ensure comprehensive product quality and adherence to regulations.
  • Risk Management Oversight: Supervise 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, particularly in diagnostics and software-integrated products.
  • Regulatory Knowledge: Extensive understanding of FDA regulations, ISO standards, and international compliance frameworks.
  • Leadership Abilities: Demonstrated capability to lead and develop QA teams, with a history of implementing strategies for continuous improvement.
  • 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 talent for thriving in a dynamic, collaborative work environment.

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