Medical Device QA Engineer: Quality & Compliance in Austin

Enovis Corporation; Austin, Northern (TX, KY); Hybrid; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Spending and Savings Accounts

401(k) Plan

Vacation, Sick Leave, and Holidays

Income Protection Plans

Discounted Insurance Rates

Legal Services

Job summary

Enovis Corporation in Austin, TX invites a Medical Device Quality Engineer to join the Quality Assurance team. You will help drive the medical technology industry forward through rigorous QA practices that ensure safety, quality, and compliance with GMP, ISO, and FDA requirements.

You will evaluate nonconforming material, analyze production data, lead root cause investigations and CAPA, support manufacturing, and help implement process validations and improvements across operations.

Qualifications

• Bachelor’s degree in science or engineering required.
• 3–5 years of experience in a regulated environment.

Responsibilities

• Evaluating nonconforming material and dispositioning based on cross-functional engineering review.
• Performing analysis of reports and production data to identify trends.
• Initiating, developing and recommending updates or changes to quality standards and procedures.
• Authoring and conducting process and equipment validations.
• Assuring compliance to GMP, ISO, FDA, CMDR.
• Leading root cause analysis and CAPA investigations.
• Supporting Manufacturing and Operations to remedy quality or compliance issues.

Education

Bachelor’s in Science or Engineering

Job description

Enovis Corporation in Austin, TX invites a Medical Device Quality Engineer to join the Quality Assurance team. You will help drive the medical technology industry forward through rigorous QA practices that ensure safety, quality, and compliance with GMP, ISO, and FDA requirements.

You will evaluate nonconforming material, analyze production data, lead root cause investigations and CAPA, support manufacturing, and help implement process validations and improvements across operations.