Quality Assurance Engineer (Medical Device)

Job Title: QA Engineer (Medical Device)
Location: Austin, TX
Reports To: Design Quality Engineering Manager
Pay: $45hr

We are seeking a QA Engineer to support sustaining engineering and operations within a regulated medical device manufacturing environment.

Responsibilities:

• Investigate customer complaints and product quality issues
• Conduct internal audits and support CAPA activities
• Review nonconforming materials and quality trends
• Ensure compliance with GMP, ISO 13485, FDA, and EU MDR standards
• Partner with engineering and operations teams on quality initiatives

Requirements:

• Bachelor’s degree in Biomedical, Mechanical, Industrial Engineering, or related field
• 3+ years of QA experience in medical device, aerospace, automotive, or other regulated industries
• Experience with ISO 13485 and quality systems
• Strong technical writing, communication, and analytical skills

Preferred:

• Oracle R12, Agile PLM, Salesforce
• CQE, Lean, or Six Sigma certification
• ISO 14971 / risk management experience
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