Medical Device Quality Engineer (GMP/ISO)

Enovis

Austin (TX)

On-site

USD 90,000 - 130,000

Full time

2 days ago

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Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation, Sick Leave, and Holidays

Income Protection Plans

Job summary

Enovis in Austin, TX is seeking a Medical Device Quality Engineer to join the Quality Assurance team. You will shape QA procedures, validate processes, and ensure compliance with GMP/ISO standards, supporting manufacturing and serving on the Material Review Board.

The ideal candidate holds a science or engineering degree with 3–5 years in regulated environments, with hands-on experience in IQ/OQ/PQ, metrology and device quality issues, and proficiency in SolidWorks and ERP tools.

Qualifications

Bachelor's degree in Science or Engineering and 3–5 years of experience.
Experience with manufacturing transfers and IQ/OQ/PQ validation in a regulated environment.
Background in Medical Device or other highly regulated industries; ISO 13485 knowledge preferred.
Proficient in technical writing and MS Office.
Understanding of manufacturing processes: metrology, precision machining, grinding, cleaning, and sterilization.

Responsibilities

Maintaining and improving quality assurance procedures and work instructions to ensure safety, quality and compliance.
Support Operations/Manufacturing; QA representative on the Material Review Board.
Lead root cause analysis and CAPA investigations.
Perform process and equipment validations.
Review trends in device failures and customer complaints.
Assist in implementing quality standards and changes.