Quality System Lead

About VPS

Vascular Perfusion Solutions is a MedTech company developing the VP.S ENCORE®, a portable hypothermic oxygenated perfusion (HOPE) platform for donor organ preservation. The system holds FDA Breakthrough Device Designation and consists of a reusable Base Unit, a single-use Perfusion Cassette, and organ-specific Cannula Kits.

The Role

We are hiring a QMS Lead to own the quality management system that carries ENCORE® through clinical use and into commercialization.

This is a builder role, not a caretaker role. Our QMS has to support design transfer to external manufacturing partners, clinical investigations in multiple jurisdictions, and eventual inspection by regulators who will not grade on effort. You will make the system real: procedures people actually follow, records that reconstruct what happened, and a document control process that does not become the bottleneck on a program with a fixed deadline.

You will work directly with the engineering team, CTO, Regulatory, our quality consultants, and our contract manufacturing partners.

What You Will Do:



Quality system ownership

• Own, build out, and maintain the QMS under ISO 13485:2016 and 21 CFR Part 820 as harmonized under the Quality Management System Regulation
• Write, revise, and release procedures and work instructions that fit how a small team actually operates
• Run management review, quality objectives, and quality metrics, and report system health to leadership
• Keep the QMS proportionate to our stage.

Document and records control

• Administer document control, change control, and record retention, including our electronic QMS
• Manage the engineering change order process end to end and keep cycle times short enough that engineering does not route around the system
• Maintain the device master record and support device history record structure for external builds

Design control and risk management

• Support design control activities and maintain the design history file, including reviews, traceability, and design transfer records
• Support risk management per ISO 14971 across dFMEA, pFMEA, and the risk management file
• Review verification and validation protocols and reports for compliance and completeness

Supplier quality

• Own supplier qualification, evaluation, and monitoring, including quality agreements and approved supplier list maintenance
• Support supplier audits, including our overseas manufacturing partner, and track corrective actions to closure
• Establish incoming inspection requirements and disposition of nonconforming material

CAPA & nonconformance

• Run the CAPA and nonconformance systems with real investigation rigor and evidence of effectiveness
• Establish complaint handling, MDR reporting, and post-market surveillance processes ahead of clinical use
• Support vigilance and reporting obligations for ex-US clinical investigations

Audit and inspection readiness

• Build and execute the internal audit program
• Prepare the organization for notified body, registrar, and FDA inspection, including front room and back room readiness
• Own training records and competency documentation across the team

What You Bring

Required

• BS in engineering, life sciences, or a related field, or equivalent hands-on experience
• 5 or more years in medical device quality, with direct responsibility for QMS elements rather than adjacent exposure
• Working command of ISO 13485:2016 and 21 CFR Part 820 as harmonized under QMSR, and the judgment to apply them at the right scale
• Hands-on experience with document control, change control, CAPA, and internal auditing
• Experience supporting design controls and design transfer for a device that reached clinical use or market
• Strong technical writing. You can produce a procedure people follow and an investigation that stands up to scrutiny
• The spine to hold a line on a compliance issue with senior people under deadline pressure
• Based in San Antonio and able to work on-site full time. This position is not remote and not hybrid
• Flexibility to travel domestically and internationally as program needs require

Preferred

• Certified auditor or lead auditor credential (ASQ CQA, Exemplar Global, or equivalent)
• Experience building or substantially rebuilding a QMS at a startup or early-stage company
• Experience supporting an IDE, Class III device, or ex-US clinical investigation
• Experience with sterilization, packaging, and shelf-life validation (ISO 11607, ISO 11135, ISO 11137)
• Familiarity with MDSAP or EU MDR
• Experience administering an electronic QMS

Who Thrives Here

This is a startup, not a business unit. There is no quality department to delegate to and no template library to inherit. The best fit is someone who has seen good systems and bad ones, knows the difference between a requirement and a habit, and will build only what the regulation and the product actually demand. You will have direct access to the CEO and the authority to say no when it matters. In exchange, we expect you to say yes quickly the rest of the time.

Why This Matters

Every year, viable donor hearts go unused because preservation time and logistics run out before a match can be reached. A quality system is what lets a device built in one country be trusted in an operating room in another. The records you build are the reason a surgeon can pick this up and believe it works.

Details

• Location: San Antonio, TX. This is an on-site position. No remote or hybrid arrangement is available
• Type: Full-time
• Travel: Flexibility to travel required, including supplier, manufacturing partner, and clinical site visits

How to Apply

Send your resume to info@vascularperfusion.solutions along with two or three sentences on a quality system you built or fixed, and one requirement you decided not to build out and why.

Vascular Perfusion Solutions is an equal opportunity employer. We evaluate all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic.