Design Quality QA Engineer - Medical Devices

Enovis; Austin (TX); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Enovis is seeking a Quality Assurance Engineer - Design Quality Focus in Austin, TX to drive design quality across NPD and sustaining programs. You will participate in design reviews, generate DFMEAs, and ensure compliance with GMP, ISO, and FDA standards, while acting as QA representative on PD initiatives.

The role requires a bachelor's in Biomedical or Mechanical Engineering with 3+ years in a design-focused QA environment or equivalent, and hands-on experience with metrology, documentation,

Qualifikationen

• Bachelor's in Biomedical or Mechanical Engineering; 3+ years in design-focused QA.
• Experience in medical device or regulated industries; ISO13485 knowledge preferred.
• Strong technical writing and metrology knowledge.

Aufgaben

• Participating in design and manufacturing reviews
• Generating DFMEAs/UFMEAs and participating in risk analysis discussions
• Reviewing and approving design and development documentation
• Serving as subject matter expert for design quality in ISO and FDA audits
• Authoring procedures and work instructions that define the quality system
• Conducting internal audits of the quality system and other business functions
• Evaluating nonconforming material and dispositioning based on cross-functional engineering review
• Assuring compliance to internal and external specifications and standards (i.e. GMP, ISO, FDA, MDD)
• Reviewing trends in device failures associated with customer complaints and nonconforming material
• Leading and owning corrective and preventive actions
• Participating in Health Hazard Evaluations
• Working on complex special projects as assigned

Kenntnisse

Quality assurance

Design reviews

Regulatory knowledge

Metrology basics

Ausbildung

Bachelor's in Biomedical or Mechanical Engineering

Tools

Solidworks

Solidworks ePDM

Oracle R12

Agile PLM

Jobbeschreibung

Enovis is seeking a Quality Assurance Engineer - Design Quality Focus in Austin, TX to drive design quality across NPD and sustaining programs. You will participate in design reviews, generate DFMEAs, and ensure compliance with GMP, ISO, and FDA standards, while acting as QA representative on PD initiatives.

The role requires a bachelor's in Biomedical or Mechanical Engineering with 3+ years in a design-focused QA environment or equivalent, and hands-on experience with metrology, documentation,