Quality Engineering Manager - Lead, Manufacturing & CAPA

Enovis Corporation; Austin (TX); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation and Holidays

Job summary

Enovis Corporation, based in Austin, Texas, seeks an Associate Manager, Quality Engineering to lead the Quality Engineering team and partner with Manufacturing to drive quality improvements. This role focuses on investigations, MRB activities, CAPA execution, and validation efforts in a regulated medical manufacturing environment.

The candidate will guide process validation, support transfers, and ensure compliance with GMP, FDA, and ISO 13485 standards while promoting a culture of continuous

Qualifications

• Bachelor’s degree in Engineering, Science, or related technical discipline.
• 5+ years of Quality/Manufacturing Engineering experience in regulated environments.
• Experience with IQ/OQ/PQ validations and CAPA processes.

Responsibilities

• Provide day-to-day leadership and guidance to Quality Engineers.
• Lead quality investigations, MRB activities, and CAPA.
• Support manufacturing transfers and process changes.
• Ensure compliance with GMP, FDA, and ISO 13485.

Skills

Quality leadership

Root cause analysis

CAPA

Process validation

Documentation

Metrology

MS Office

Education

Bachelor’s degree in Engineering/Science

Tools

Excel

Word

PowerPoint

Job description

Enovis Corporation, based in Austin, Texas, seeks an Associate Manager, Quality Engineering to lead the Quality Engineering team and partner with Manufacturing to drive quality improvements. This role focuses on investigations, MRB activities, CAPA execution, and validation efforts in a regulated medical manufacturing environment.

The candidate will guide process validation, support transfers, and ensure compliance with GMP, FDA, and ISO 13485 standards while promoting a culture of continuous