Medical Device Quality Engineer — ISO 13485 & GMP

Encore Medical LP; Austin (TX); On-site; USD 75,000 - 105,000; 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 Corporation in Austin, TX is seeking a Medical Device Quality Engineer to join the Quality Engineering team. You will evaluate nonconforming material, analyze production data, and lead validations, ensuring compliance with GMP, ISO, and FDA standards.

The role focuses on root cause analysis, CAPA investigations, and collaboration with Manufacturing to address quality issues. A BS in engineering with 3–5 years in regulated industries is required.

Qualifications

• BS in Science or Engineering and 3–5 years of experience in regulated industries.
• Background in Medical Device, Aeronautics, Automotive or similar; ISO 13485 knowledge preferred.
• Strong technical writing and quality documentation practices.
• Basic knowledge of manufacturing processes: metrology, precision machining, grinding, cleaning, sterilization.
• Experience with GMP/ISO/FDA compliance and QA software tools is a plus.

Responsibilities

• Evaluating nonconforming material and dispositioning via cross-functional review.
• Analyzing reports and production data to identify trends.
• Developing updates to quality standards and procedures.
• Authoring and conducting process and equipment validations.
• Ensuring compliance with GMP, ISO, FDA, and CMDR.
• Reviewing device failure trends and leading root cause analyses.
• Leading CAPA investigations and supporting remediation with Manufacturing.

Skills

CQE/Lean/6Sigma

English communication

MS Office proficiency

Education

Bachelor’s in Science or Engineering

Tools

Solidworks

Solidworks ePDM

Oracle R12

Agile PLM

Job description

Enovis Corporation in Austin, TX is seeking a Medical Device Quality Engineer to join the Quality Engineering team. You will evaluate nonconforming material, analyze production data, and lead validations, ensuring compliance with GMP, ISO, and FDA standards.

The role focuses on root cause analysis, CAPA investigations, and collaboration with Manufacturing to address quality issues. A BS in engineering with 3–5 years in regulated industries is required.