Medical Device QA & Regulatory Engineer

Enovis Corp; Austin (TX); On-site; USD 75,000 - 95,000; Full time

Job summary

Enovis Corp is seeking an RA/QA Engineer in Austin, Texas. This full-time role involves maintaining quality assurance procedures, supporting New Product Development, and ensuring compliance with ISO and FDA regulations. Candidates should possess a Bachelor's degree in Biomedical or Mechanical Engineering, along with 2+ years of relevant experience. Desired skills include knowledge in metrology and proficiency in Microsoft Office. The position offers opportunities to work on complex projects in a supportive team environment focused on continual improvement.

Qualifications

• 2+ years of experience in a regulated industry.
• Familiarity with ISO13485 quality standards.
• Knowledge of metrology, precision machining, and product cleaning.

Responsibilities

• Support sustaining and special instrument teams.
• Participate in design and manufacturing reviews.
• Conduct internal audits of the quality system.

Skills

Biomedical or Mechanical Engineering

Medical Device Background

Technical Writing Quality

Knowledge of Quality Regulations

Advanced proficiency in Microsoft Excel and Word

Education

Bachelor’s degree in Biomedical or Mechanical Engineering

Tools

Solidworks

Oracle R12

Agile PLM

Job description

Enovis Corp is seeking an RA/QA Engineer in Austin, Texas. This full-time role involves maintaining quality assurance procedures, supporting New Product Development, and ensuring compliance with ISO and FDA regulations. Candidates should possess a Bachelor's degree in Biomedical or Mechanical Engineering, along with 2+ years of relevant experience. Desired skills include knowledge in metrology and proficiency in Microsoft Office. The position offers opportunities to work on complex projects in a supportive team environment focused on continual improvement.