Project Manager, Quality Engineering, Regulatory Compliance Specialist

Verification and Validation, Design Transfer, and Manufacturing Readiness

Location: San Antonio, TX (onsite). Open to hybrid for a candidate with the right qualifications.

Type: Full time, exempt/ Open to Part time for a candidate with the right qualifications.

Reports to: President and CEO

Level: Individual contributor, senior level. This is a hands on execution role, not a people management or director level position.

VPS is a pre-clinical-stage Med Tech company developing the VP.S ENCORE® system, a portable platform for hypothermic oxygenated perfusion of donor organs, focused on heart transplantation with adult and pediatric applications and a pipeline targeting multi-organ preservation and ex vivo therapeutic use. The VP.S ENCORE® holds FDA Breakthrough Device Designation.

We are in the late stages of design freeze and in the most demanding phase of the program: verification and validation, design transfer, and manufacturing of units under a compliant quality system in preparation for first-inhuman. Timelines are fixed and externally committed. We need someone who treats a date as a date.

You will own the schedule and the execution discipline for the VP.S ENCORE® program from V&V protocol authoring through protocol execution, report closure, and design transfer to contract manufacturing. You will not be writing the engineering solutions, and you will not be running the quality system. You will be the person who makes sure the right work is defined, sequenced, resourced, started on time, and finished to the standard required by a Class III submission.

This is a driving role. You will hold engineers, scientists, consultants, and suppliers accountable to commitments they made, surface slips before they become slips, and push hard for closure without burning the team down. The best person for this job is respected because they are relentless and fair, not because they have a title.

• Build and maintain the integrated master schedule across design control, V&V, risk management, manufacturing transfer, and regulatory deliverables, with real critical path analysis and dependency mapping.
• Run the weekly execution cadence: agenda, decisions, owners, due dates, and follow through. Meetings end with commitments, not discussion.
• Identify schedule risk early, model recovery options, and bring the CEO decisions rather than problems.
• Track and close open items across internal team members, external consultants (quality, regulatory, electrical engineering), and suppliers.

• Coordinate the full V&V lifecycle: protocol drafting and review, protocol approval, sample and unit availability, test execution scheduling, deviation handling, data review, and report closure.
• Maintain the requirements and traceability matrix from user needs through design inputs, design outputs, verification, and validation.
• Coordinate external testing activities including biocompatibility (ISO 10993), electrical safety and EMC (IEC 60601 series), packaging and sterilization validation, shelf life, and bench or animal validation work.
• Ensure test units are built, configured, and documented correctly before test windows open. Nothing kills a schedule faster than a test slot missed for lack of a unit.

• Drive completion of the Device Master Record: drawings, specifications, bills of material, work instructions, assembly and inspection procedures, acceptance criteria, and labeling.
• Identify and close DMR and DHF gaps against a defined readiness checklist.
• Coordinate process validation activities (IQ, OQ, PQ) and first article inspection with the contract manufacturer.
• Manage supplier deliverables, quality agreements, incoming inspection criteria, and component qualification timelines.
• Coordinate build planning for V&V and clinical units, including lot traceability and Device History Record completeness.

• Ensure work is executed inside the quality system, not around it. Change control, ECOs, nonconformances, deviations, and CAPAs get raised and closed properly.
• Partner with the quality function and…