Design Quality Assurance Specialist
1 week ago
Mondo is seeking a skilled Design Quality Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the design and manufacturing of medical devices meet the highest standards of quality and regulatory compliance.
Key Responsibilities:- Document review and risk management
- Change management and CAPA implementation
- Interacting with R&D to identify qualification work and end-of-life related issues
- Leading FMEAS for medical devices and sustaining design
- 2+ years of experience in design for medical devices
- Knowledge of design controls and external standards (e.g. EUMDR)
- CAPAS resolution plans and standards changes
- Six sigma and problem-solving skills
- Hands-on design V&VI, QO, and PQRisk management and design history files
- Greenbelt certification
- Risk management experience
Mondo offers a competitive compensation package and opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality and design, we encourage you to apply for this exciting opportunity.
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