What are the responsibilities and job description for the Quality Assurance Engineer (Medical Device) position at TalenTier?
Job Title: QA Engineer (Medical Device)
Location: Fort Worth, 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
Salary : $45