Design Quality Assurance Specialist
1 day ago
Job Title: Design Quality Engineer
Job Type: Long-term Contract Position
Location: Remote (Westford, MA)
Job Summary: Mondo is seeking a highly skilled Design Quality Engineer to join our team. As a Design Quality Engineer, you will be responsible for ensuring the quality and integrity of our medical devices.
Key Responsibilities:
- Document Review: Conduct thorough reviews of design documents to ensure compliance with risk management and quality standards.
- CAPAS and Change Management: Implement CAPAS and change management processes to ensure seamless transitions and minimize risks.
- Interactions with R&D: Collaborate with R&D teams to identify and address quality-related issues.
- Qualification Work and End-of-Life Issues: Identify and resolve qualification work and end-of-life related issues.
- FMEAS and Sustaining Design: Conduct FMEAS and sustaining design activities to ensure ongoing quality and integrity.
Requirements:
- 2+ Years of Experience: Minimum 2 years of experience in design for medical devices.
- Design Controls and External Standards: Knowledge of design controls and external standards (e.g., EUMDR).
- CAPAS and Six Sigma: Experience with CAPAS and six sigma methodologies.
- Hands-on Design V&V: Hands-on experience with design verification and validation.
- Risk Management: Strong understanding of risk management principles and processes.
Preferred Qualifications:
- Greenbelt Certification: Greenbelt certification or equivalent experience.
- Risk Management: Experience with risk management processes and principles.
About Mondo: Mondo is a leading provider of contract staffing solutions. We are committed to delivering exceptional service and quality to our clients and candidates.
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