Design Quality Assurance Specialist

1 day ago


Westford, Massachusetts, United States Mondo Full time

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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