Quality Systems Leader: QMS Strategy & Compliance

Prospect Life Sciences; Denver (CO); On-site; USD 120,000 - 160,000; Full time

Job summary

Prospect Life Sciences in Denver, CO seeks a Quality Engineering Manager to own and advance the Quality Management System, ensuring compliance with FDA QSR, ISO standards, and product lifecycle requirements.

You will lead cross-functional teams, drive audits, process improvements, and supplier and internal quality programs while collaborating with senior leadership.

This role emphasizes scalable quality systems, risk management, and the integration of AI-enabled automation to support growth.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 8+ years in FDA-regulated medical device QMS.
• Experience implementing QMSR, ISO 13485:2016, ISO 14971.
• Experience leading audits (internal, supplier, process).
• Ability to lead cross-functional teams and manage quality performance.

Responsibilities

• Provide strategic leadership for the QMS and ensure regulatory compliance.
• Lead audits, risk management, design controls, and manufacturing readiness.
• Drive continuous improvement and scalable quality systems.
• Collaborate with CEO/Head of Product Development and Operations.
• Oversee client programs and quality deliverables.

Skills

Leadership

Cross-functional leadership

Quality systems

Regulatory compliance

Project management

Audits

Process improvement

AI-enabled automation

Education

Bachelor's degree

Job description

Prospect Life Sciences in Denver, CO seeks a Quality Engineering Manager to own and advance the Quality Management System, ensuring compliance with FDA QSR, ISO standards, and product lifecycle requirements.

You will lead cross-functional teams, drive audits, process improvements, and supplier and internal quality programs while collaborating with senior leadership.

This role emphasizes scalable quality systems, risk management, and the integration of AI-enabled automation to support growth.