Quality Director – Medical Device, USCT

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership and enhance the Quality Management System (QMS) to support a regulated medical device development initiative, which includes design controls and maintaining the Design History File (DHF).

• Define and implement requirements traceability: from user needs to design requirements, verification/validation artifacts, and change control.

• Develop and execute the program-level Verification and Validation (V&V) strategy, which encompasses test plans, protocols, reports, and acceptance criteria.

• Lead risk management efforts, such as DFMEA / PFMEA and hazard analyses, ensuring that mitigations are incorporated into requirements and verification processes.

• Oversee document control processes: including reviews, approvals, training, retention, and preparation for audits.

• Collaborate with engineering teams to integrate quality seamlessly into the development workflow, including automated testing, release gates, and software configuration management.

• Prepare the program for audits and inspections, taking on a hands-on role in audit leadership.

⛳️ Requirements

• Extensive experience in leading quality for intricate hardware and software products within a regulated setting.

• Profound understanding of design controls, DHF, document control, risk management, and verification planning.

• Strong systems-oriented mindset, capable of converting ambiguous product intentions into measurable requirements.

• Comfortable working collaboratively with multidisciplinary engineering teams, including recon/ML, embedded systems, mechanical, electrical engineering, and cloud.

🏝️ Benefits

• Health insurance

• 401(k)

• Paid time off

• Professional development opportunities