Director Quality Systems

Location:

Draper, UT (In office required)

Job Title:

Director of Quality Systems Reports to:

CEO Company:

Xenter Inc, A TechMed Company About Us 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 guidewires and catheters that transmit data through a proprietary wireless network to our proprietary cloud that collects and houses real-time Physical Intelligence medical data. Position Summary 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. Key Responsibilities Quality Management System Leadership 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. Design Controls & Product Development Support 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. CAPA & Post-Market Systems 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. Supplier & Manufacturing Quality 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. Inspection & Audit Readiness 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.

Qualifications Required:

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.

Preferred:

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.