Quality Systems Lead — QMS & Regulatory Excellence

Zimmer Biomet; Austin (TX); On-site; USD 100,000 - 124,000; Full time

Job summary

Zimmer Biomet in Austin, TX, seeks a Quality Systems leader to drive the QMS for robotic surgical systems, overseeing document control, change control, training, and audit readiness.

You will collaborate across Engineering, Regulatory, Clinical, Operations, and Supply Chain to ensure ISO 13485 and FDA QMSR compliance and support regulatory submissions.

Travel up to 25%; Bachelor’s in Engineering with 5+ years in medical device quality systems; ASQ CQ A or CMQ/OE preferred.

Qualifications

• Bachelor's degree in Engineering required; 5+ years in medical device quality systems.
• Experience with FDA QMSR and ISO 13485.
• Experience leading document control, change control, training, and audits.
• ASQ CQ A, CMQ/OE or equivalent certification preferred.

Responsibilities

• Lead or support the implementation, maintenance, and continuous improvement of the QMS.
• Develop, implement, and maintain Document Control and Change Control processes.
• Lead or support the Monogram Training Program, ensuring training assignments, completion, and records compliance.
• Serve as the Quality Systems SME for Greenlight Guru and future eQMS platforms.
• Develop, maintain, and continually improve Quality System procedures, work instructions, forms, templates, and records.
• Partner with Engineering, Regulatory Affairs, Clinical, Operations, and Supply Chain to ensure lifecycle quality.
• Support regulatory submissions with complete, controlled documentation.
• Lead internal and external audits and regulatory inspections; coordinate corrective actions.

Skills

FDA QMSR

ISO 13485

Document Control

Change Control

Training Systems

Audits

PQS

Risk Management

Quality Metrics

Cross-functional Leadership

Education

Bachelor's Degree in Engineering

Tools

Greenlight Guru

SmartSolve

Windchill

ETQ

Job description

Zimmer Biomet in Austin, TX, seeks a Quality Systems leader to drive the QMS for robotic surgical systems, overseeing document control, change control, training, and audit readiness.

You will collaborate across Engineering, Regulatory, Clinical, Operations, and Supply Chain to ensure ISO 13485 and FDA QMSR compliance and support regulatory submissions.

Travel up to 25%; Bachelor’s in Engineering with 5+ years in medical device quality systems; ASQ CQ A or CMQ/OE preferred.