Quality Engineering Lead - Medical Devices

Enovis; Austin (TX); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, and Holidays

Income Protection Plans

Discounted Insurance Rates

Legal Services

Job summary

Enovis is seeking an Associate Manager, Quality Engineering in Austin, TX. You will lead the Quality Engineering team, drive investigations, MRB activities, and continuous improvement across manufacturing operations.

The role emphasizes collaboration with Manufacturing, Engineering, and Operations to ensure GMP and ISO 13485 compliance while guiding CAPA and risk-based decision making.

Qualifications

• Bachelor's degree in Engineering, Science, or related field.
• 5+ years in Quality/Manufacturing engineering in a regulated setting.
• Experience in Medical Device or similarly regulated industries preferred.
• Experience leading projects and mentoring teams.
• Experience with IQ/OQ/PQ validation and CAPA processes.

Responsibilities

• Provide day-to-day technical guidance to Quality Engineers.
• Lead quality investigations and MRB activities.
• Manage team priorities, resources, and development plans.
• Lead risk-based decision making for deviations and changes.
• Monitor quality metrics and drive continual improvement.

Skills

Quality Leadership

Root Cause Analysis

CAPA

Regulatory Knowledge

Process Improvement

Documentation

Cross-functional Collaboration

Education

Bachelor's degree in Engineering/Science

Tools

IQ/OQ/PQ

MS Excel

Job description

Enovis is seeking an Associate Manager, Quality Engineering in Austin, TX. You will lead the Quality Engineering team, drive investigations, MRB activities, and continuous improvement across manufacturing operations.

The role emphasizes collaboration with Manufacturing, Engineering, and Operations to ensure GMP and ISO 13485 compliance while guiding CAPA and risk-based decision making.