Quality Assurance Engineer (Medical Device)
TalenTier · Fort Worth, TX · 1 wk ago
On-siteQuality Assurance$45/hrContract
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