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Head of Quality Assurance

2 months ago

Minnesota, United States X4 Life Sciences Full time

Quality Assurance Director

X4 Life Sciences is committed to enhancing patient outcomes through innovative technology and superior products. In the role of Quality Assurance Director, you will be instrumental in guaranteeing the quality, safety, and regulatory compliance of diagnostic and software-based medical devices. This strategic leadership position involves guiding the Quality Assurance (QA) team, spearheading continuous improvement efforts, and ensuring our offerings adhere to both internal benchmarks and regulatory standards.

Core Responsibilities:

  • Oversee QA Operations: Manage all quality assurance functions, including the establishment and upkeep of Quality Management Systems (QMS) that align with FDA, ISO, and international standards.
  • Ensure Regulatory Adherence: Confirm that all products meet applicable regulations, including FDA (21 CFR Part 820 and 11), ISO 13485, ISO 14971, and global standards such as EU MDR/IVDR.
  • Manage Product Lifecycle: Navigate products through every phase of their lifecycle, from conception and development to regulatory clearance and post-market monitoring.
  • Lead and Develop Teams: Direct and mentor the QA team, promoting a culture centered on quality and ongoing enhancement.
  • Facilitate Cross-Department Collaboration: Collaborate closely with R&D, Regulatory Affairs, Manufacturing, and other essential divisions to uphold product quality and compliance.
  • Implement Risk Management: Supervise risk management protocols in line with ISO 14971, ensuring that potential risks are recognized and addressed.

Required Qualifications:

  • Professional Experience: A minimum of 10 years in Quality Assurance within the medical device sector, particularly in diagnostics and software-driven solutions.
  • Regulatory Expertise: Comprehensive knowledge of FDA regulations, ISO standards, and international regulatory frameworks.
  • Leadership Skills: Demonstrated experience in leading and nurturing QA teams, with a history of promoting 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 advantageous.
  • Essential Skills: Exceptional communication and leadership abilities, with a proven capacity to thrive in a dynamic, collaborative environment.