Design Quality Engineer - Medical Devices

Enovis; Austin (TX); On-site; USD 95,000 - 120,000; Full time

Job summary

Enovis, a medical technology company in Austin, TX, seeks a Quality Assurance Engineer - Design Quality Focus to ensure external safety, quality and compliance with GMP and FDA standards. You will support New Product Development and Sustaining PD initiatives as QA representative.

Responsibilities include design reviews, DFMEAs/UFMEAs, audits, ISO/FDA readiness, and developing quality procedures, with up to 10% travel.

Qualifications

• Bachelor's in Biomedical or Mechanical Engineering and 3+ years of experience, with at least 1 year in design focused environment.
• Background in Medical Device or other highly regulated industry; ISO13485 knowledge preferred.
• Technical writing quality and best practices; familiarity with GMP, ISO, FDA, MDD.

Responsibilities

• Participating in design and manufacturing reviews.
• Generating DFMEAs/UFMEAs and risk analysis discussions.
• Reviewing and approving design and development documentation.
• Serve as SME for design quality in ISO and FDA audits.
• Authoring procedures and work instructions that govern the quality system.
• Conduct internal audits of the quality system and other functions.
• Lead corrective and preventive actions.

Skills

Quality Assurance

Design Quality

Risk Management

Technical writing

Audits (ISO/FDA)

Education

Bachelor's in Biomedical or Mechanical Engineering

Tools

SolidWorks

SolidWorks ePDM

Oracle R12

Agile PLM

Job description

Enovis, a medical technology company in Austin, TX, seeks a Quality Assurance Engineer - Design Quality Focus to ensure external safety, quality and compliance with GMP and FDA standards. You will support New Product Development and Sustaining PD initiatives as QA representative.

Responsibilities include design reviews, DFMEAs/UFMEAs, audits, ISO/FDA readiness, and developing quality procedures, with up to 10% travel.