Quality Engineer – Medical Device Design Quality Full Time NEW

Job Title:

Quality Assurance Engineer – Design Quality

Reports To:

Design Quality Engineering Manager

Location:

Austin, TX (Candidate must reside in Texas)

Business Unit:

Medical Device Engineering & Product Development

Position Summary:

This role uses strong engineering and problem‑solving skills to design, implement, and improve quality assurance processes that ensure product safety, reliability, and compliance with medical device regulations. The position supports New Product Development (NPD) and Sustaining Engineering and serves as the primary Design Quality representative across cross‑functional initiatives.

Key Responsibilities:

• Support new product development and sustaining engineering teams throughout the product lifecycle

• Participate in design reviews, manufacturing reviews, and technical discussions

• Generate DFMEAs/UFMEAs and contribute to risk management activities

• Review and approve design and development documentation

• Serve as the Design Quality subject matter expert during ISO and FDA audits

• Author and maintain procedures, work instructions, and quality system documentation

• Conduct internal audits across quality system and operational functions

• Evaluate nonconforming material and determine disposition through cross‑functional review

• Ensure compliance with internal and external standards (GMP, ISO 13485, FDA QSR, MDR)

• Analyze trends in device failures, complaints, and nonconforming material

• Lead and manage corrective and preventive actions (CAPA)

• Support Health Hazard Evaluations (HHEs) as assigned

• Execute complex quality engineering projects as needed

Minimum Qualifications:

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field

• Minimum of 2 years of experience in quality or product development, including at least 1 year in design or development quality

• Experience in the medical device industry or other highly regulated sectors (aerospace, automotive, etc.)

• Proficiency with Microsoft Office Suite or equivalent tools

• Must be located in Texas

Desired Characteristics:

• Experience with SolidWorks, SolidWorks ePDM, Oracle R12, or Agile PLM

• Working knowledge of ISO 13485 and FDA QSR requirements

• CQE, Lean, or Six Sigma certification preferred

• Strong understanding of ISO 14971 and risk management principles

• Skilled in technical writing and documentation best practices

• Familiarity with manufacturing processes such as metrology, precision machining, grinding, cleaning, and sterilization

• Highly detail‑oriented with strong analytical skills

If you want, I can also create a shorter LinkedIn version, a recruiter outreach message, or a more junior‑friendly variant.