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Sr. Design Quality Engineer

Snap Staffing

Sr. Design Quality Engineer

Aliso Viejo, CA
Full Time
Paid
  • Responsibilities

    Design Quality Engineer (Aliso Viejo, CA $95K)

    SNAPSHOT!

    Smart Technology, growing medical device company, has an immediate opening for a Sr. Design Quality Engineer responsible for performing design quality activities and supporting on-market products, new product development, and continual process improvement initiatives. Located in Aliso Viejo, California, our client is a well-established, worldwide leader in orthopedic medical devices, committed to providing orthopedic surgeons with user-friendly, cost-effective, cutting-edge technology for precise alignment during hip and knee replacement surgery.

    Immediate Opening for a Sr. Design Quality Engineer in Aliso Viejo, CA who possesses:

    • Provide quality assurance input and review of design and development planning, inputs/outputs of development, design reviews, design validation and verification, human factors analysis, design history file, and device master record development and maintenance.
    • Drive risk management file establishment and maintenance throughout the product life-cycle. Assist in establishing hazards list, assessing the severity of harm and ensuring consistency between risk management files on systems.
    • Lead CAPA investigations and support CAPA investigation teams relating to product functionality and design improvement. Support audits of the quality management system, specifically relating to Design Control, Risk Management, CAPA, Complaints, and related processes.
    • Assist the development team in creating, optimizing and validating mechanical and analytical test methods. Supporting regulatory submissions by reviewing content for accuracy and comprehensiveness.
    • Identify, propose and drive opportunities for improvement, including review and revision of procedures and associated documents.

    We offer:

    • Competitive pay and career track advancement
    • 100% paid medical & dental coverage.
    • 50% medical and dental coverage for dependents.

     

    For immediate consideration, please send your resume to admin@snapstaffing.com!