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Design Quality Assurance Specialist

2 months ago

Westford, Massachusetts, United States Mondo Staffing Full time
Design Quality Engineer

Mondo Staffing is seeking a skilled Design Quality Engineer to join our team. As a Design Quality Engineer, you will be responsible for ensuring the quality and safety of medical devices.

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
Requirements:
  • 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&V, IQ, OQ, PQ, and risk management experience
Preferred Qualifications:
  • Greenbelt certification in risk management

Mondo Staffing offers a competitive compensation range of $35-40 per hour and eligibility for health insurance and retirement plans. If you are a motivated and detail-oriented individual with a passion for quality and safety, we encourage you to apply for this exciting opportunity.