Onsite Medical Device Quality Engineer (Austin)

Enovis Healthcare Solutions; Austin (TX); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation

Job summary

Enovis Austin seeks a Medical Device Quality Engineer to support QA activities, ensure GMP/ISO compliance, and assist with validations and CAPA. You will work closely with Manufacturing to address quality concerns and participate in audits, while applying structured problem solving and thorough documentation.

The role requires a bachelor's degree in engineering or related field, 0–2 years' experience, and the ability to work 100% onsite at the Austin facility.

Qualifications

• Bachelor’s degree in Engineering, Science, or related technical field required.
• Knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
• Basic documentation practices and quality best practices.
• Ability to write clear, concise technical documentation.
• Onsite work at the Austin manufacturing facility; MS Office proficiency.
• Lift up to 50 lbs and perform physical requirements as needed.

Responsibilities

• Support QA activities for implementation, maintenance, and improvement of procedures.
• Ensure compliance with GMP, ISO, FDA, CMDR requirements.
• Assist with MRB activities and disposition of nonconforming material.
• Assist with process and equipment validations (IQ/OQ/PQ).
• Support supplier quality, SCARs, audits, and supplier performance.
• Contribute to CAPA, root cause investigations, and data trend analysis.
• Participate in internal and external audits and close findings.

Skills

Quality engineering

Documentation

MS Office

Problem solving

Education

Bachelor’s degree in Engineering, Science, or related field

Tools

SolidWorks

Oracle R12

Agile PLM

SolidWorks ePDM

Job description

Enovis Austin seeks a Medical Device Quality Engineer to support QA activities, ensure GMP/ISO compliance, and assist with validations and CAPA. You will work closely with Manufacturing to address quality concerns and participate in audits, while applying structured problem solving and thorough documentation.

The role requires a bachelor's degree in engineering or related field, 0–2 years' experience, and the ability to work 100% onsite at the Austin facility.