Design Quality Engineer

TL;DR

Design Quality Engineer (QA/Medical Devices): Own and execute design-quality assurance activities across New Product Development and Sustaining Product Development, with an accent on ISO/FDA audit readiness, risk analysis, and quality-system documentation. Focus on generating DFMEAs/UFMEAs, reviewing design and development documentation, leading corrective and preventive actions, and ensuring compliance to GMP/ISO/FDA/MDD requirements.

Location: USA, Texas, Austin

Company

hirify.global is an innovation-driven medical technology company developing clinically differentiated solutions for improved patient outcomes.

What you will do

• Serve as the QA representative on product development initiatives, including sustaining and special instrument teams.
• Participate in design and manufacturing reviews and review/approve design and development documentation.
• Generate DFMEAs/UFMEAs and lead risk analysis discussions.
• Act as a subject matter expert for design quality in ISO and FDA audits.
• Author quality system procedures and work instructions; conduct internal audits of the quality system and other business functions.
• Evaluate nonconforming material, lead corrective and preventive actions, and review device failure trends tied to customer complaints.

Requirements

• Bachelor’s degree in Biomedical or Mechanical Engineering and 3+ years of experience.
• Background in Medical Device, Aeronautics, Automotive, or another highly regulated industry; preferred knowledge of ISO 13485.
• Knowledge of technical writing quality and best practices.
• Basic knowledge of manufacturing processes with focus on metrology, precision machining, grinding, product cleaning, and sterilization.
• Working knowledge of US and international quality system regulations.
• Fluent English (oral and written).

Culture & Benefits

• General office work environment with low to moderate noise.
• Up to 10% travel.
• Quality-system and regulatory focus supporting continuous improvement.