What are the responsibilities and job description for the Senior Quality Engineer position at X4 Life Sciences?
🚀 Senior Quality Engineer | SaMD | Dallas, TX
Are you an experienced Quality Engineer looking to take the next step in your career with a fast-growing and innovative healthcare technology company?
X4 Life Sciences is supporting a rapidly expanding Software as a Medical Device (SaMD) organisation based in Dallas, Texas, in their search for a Senior Quality Engineer. This is a fantastic opportunity to join a business that is transforming patient care through cutting-edge software solutions and is entering an exciting phase of growth.
As a Senior Quality Engineer, you will play a critical role in maintaining and enhancing the company's quality systems while partnering closely with cross-functional teams across Software Engineering, Regulatory Affairs, Product Development, and Operations. This is an ideal position for someone who enjoys working in a dynamic, fast-paced environment and is excited by the opportunity to influence quality strategy as the organisation scales.
Key Responsibilities:
- Support and continuously improve the Quality Management System (QMS)
- Partner with development teams to ensure compliance throughout the software development lifecycle
- Lead and support internal audits, CAPAs, non-conformances, and quality improvement initiatives
- Contribute to regulatory submissions and quality documentation
- Drive compliance with applicable regulations and industry standards
- Act as a key quality representative across multiple business functions
What We're Looking For:
✔ Experience within the Software as a Medical Device (SaMD) industry
✔ Strong working knowledge of ISO 13485 and IEC 62304
✔ Experience supporting FDA 510(k) submissions is highly desirable
✔ Understanding of software quality and risk management principles within regulated environments
✔ Ability to work independently while collaborating effectively across teams
✔ A proactive, hands-on approach and the willingness to wear multiple hats in a growing organisation
Why This Opportunity?
This is more than just another Quality Engineering role. You'll be joining a company where quality is viewed as a strategic function, giving you the opportunity to have a direct impact on products, processes, and business growth. The leadership team is committed to investing in its people, making this an excellent opportunity for someone seeking long-term career development and progression.
The company offers a collaborative, mission-driven culture where individuals are empowered to take ownership, contribute new ideas, and help shape the future of the organisation.
Location & Working Arrangement:
📍 Dallas, Texas
🏠 Hybrid working model – 3 days onsite, 2 days remote
If you're interested in learning more about this opportunity, please reach out directly:
📩 o.archer@x4lifesciences.com