Quality Director
Based in Minnesota, dedicated to improving patient outcomes through cutting-edge technology and high-quality products. As the Director of Quality Assurance, you will play a crucial role in ensuring the quality, safety, and compliance of diagnostic and software-driven medical devices. You will lead the Quality Assurance (QA) team, driving continuous improvement initiatives, and ensuring that our products meet both internal standards and regulatory requirements. This is a strategic leadership position where you will collaborate closely with R&D, Regulatory Affairs, Manufacturing, and other key departments to bring innovative medical devices to market.
Key Responsibilities:
- Lead the QA Function: Oversee all quality assurance activities, including the implementation and maintenance of Quality Management Systems (QMS) in compliance with FDA, ISO, and global standards.
- Regulatory Compliance: Ensure all products comply with relevant regulations, including FDA (21 CFR Part 820 and 11), ISO 13485, ISO 14971, and global standards such as EU MDR/IVDR.
- Product Lifecycle Management: Guide products through all stages of the lifecycle, from design and development to regulatory approval and post-market surveillance.
- Team Leadership: Manage and mentor the QA team, fostering a culture of quality and continuous improvement.
- Cross-Functional Collaboration: Work closely with R&D, Regulatory Affairs, Manufacturing, and other departments to ensure product quality and compliance across the board.
- Risk Management: Oversee risk management processes in accordance with ISO 14971, ensuring potential risks are identified and mitigated.
Qualifications:
- Experience: 10+ years of experience in Quality Assurance within the medical device industry, with a focus on diagnostics and software-driven products.
- Regulatory Knowledge: Strong understanding of FDA regulations, ISO standards, and global regulatory frameworks.
- Leadership: Proven experience leading and developing QA teams, with a track record of driving continuous improvement initiatives.
- Education: Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field. Advanced certifications in Quality Assurance or Regulatory Affairs are a plus.
- Skills: Excellent communication and leadership skills, with the ability to work effectively in a fast-paced, collaborative environment.
