Director Quality Systems

Location: Draper, UT (In office required)

Job Title: Director of Quality Systems

Reports to: CEO Company: Xenter Inc, A Tech Med Company

Xenter is a technology in medicine company that is bringing medical devices to the digital age. Xenter is revolutionizing medicine by developing and launching smart/wireless guide wires and catheters that transmit data through a proprietary wireless network to our proprietary cloud that collects and houses real-time Physical Intelligence medical data.

The Director of Quality Systems will lead the development, implementation, and continuous improvement of our Quality Management System (QMS). This leader will ensure compliance with:

• 21 CFR Part 820
• ISO 13485
• Applicable FDA and global regulatory requirements

This is a strategic and hands‑on leadership role responsible for inspection readiness, scalable quality infrastructure, and cross‑functional integration across product development, manufacturing, and post‑market activities.

• Build and scale a compliant QMS suitable for a pre‑IPO organization.
• Ensure alignment with FDA Quality System Regulation and ISO 13485.
• Lead document control, training systems, and record retention programs.
• Establish quality KPIs and executive‑level reporting metrics.

• Oversee design control processes (DHF, DMR, DHR).
• Ensure effective implementation of risk management (ISO 14971 alignment).
• Partner with Engineering and Regulatory on verification/validation planning.
• Support software validation and cybersecurity documentation for digital health products.
• Ensure quality oversight of design changes and product lifecycle management.

• Lead CAPA program, including root cause analysis and effectiveness checks.
• Oversee complaint handling and MDR evaluation processes.
• Implement trending and data analytics to drive continuous improvement.
• Ensure robust post‑market surveillance systems are in place.

• Establish supplier qualification and monitoring processes.
• Oversee quality agreements and supplier audits.
• Ensure process validation and production controls are documented and compliant.
• Support contract manufacturing oversight.

• Serve as quality lead during FDA inspections and external audits.
• Conduct internal audits and manage remediation plans.
• Prepare executive leadership for agency interactions with the U.S. Food and Drug Administration.
• Ensure readiness for ISO 13485 certification and surveillance audits.

• Bachelor’s degree in engineering, life sciences, or related field.
• 10+ years of quality systems experience in medical devices.
• Deep working knowledge of 21 CFR Part 820 and ISO 13485.
• Experience supporting Class II 510(k) products.
• Demonstrated experience leading FDA inspections or ISO audits.
• Strong CAPA and risk management expertise.

• Experience in a venture-backed or pre-IPO environment.
• Experience with software-enabled or connected medical devices.
• ASQ Certified Quality Auditor (CQA) or related certification.
• Experience implementing eQMS systems.