Senior Design Quality Engineer

146568
  • 120000 USD - 140000 USD
  • Carlsbad, United States
  • Permanent

Job Overview

As a Quality Engineer in New Product Development, you will leverage your expertise in quality engineering to ensure our products comply with regulatory standards and the companies procedures. Your role will optimize product development, manufacturing, and distribution processes, both internally and externally.

Responsibilities

  • Develop and implement engineering solutions focused on Quality Assurance, Design Controls, Risk Management, and Statistical Techniques.
  • Lead design assurance and development activities for new product development, including engineering studies, feasibility testing, and drawing reviews.
  • Create and maintain risk management files in line with ISO 14971 and relevant regulations, covering plans, hazard analyses, FMEAs, software hazard analysis, and reports.
  • Formulate quality assurance specifications, test methods, inspection procedures, sampling plans, and associated documentation.
  • Oversee test method development and validation processes.
  • Support new product launches, master validation plans, product verification and validation (V&V), process validations, and design transfer to manufacturing.
  • Provide daily support for production needs and address issues by actively participating in assembly operations. Continuously improve methods and systems to achieve full compliance and world-class manufacturing standards.
  • Implement and review changes to existing products, SOPs, Work Instructions, Test Methods, Process Changes, Design Changes, Labeling, and Field Issues to determine regulatory submission and notification requirements.
  • Prepare and support documentation for regulatory submissions and global registrations.
  • Assist in the Supplier Evaluation, Selection, and Qualification processes.
  • Perform additional duties as needed.

Qualifications

  • Bachelor's degree in Engineering or a related scientific field with a minimum of 4 years of experience in Quality Engineering, Quality Manufacturing, or R&D; OR a Master's degree in Engineering or a related scientific field with a minimum of 2 years of experience in Quality Engineering, Quality Manufacturing, or R&D.
  • Hands-on experience in Design Assurance, including Design Controls, Design Freeze (or pre-design freeze feasibility testing), Design Verification & Validation, and/or Design Test Method Development.
  • Experience in a highly regulated industry is essential.
  • Familiarity with Software Development Life Cycle Processes in accordance with IEC 62304 is highly preferred.
  • Knowledge of Usability Engineering Processes in accordance with IEC 62366 is highly preferred.

Environment and Physical Activities/Requirements

  • This position is based in an indoor office environment with no expected adverse conditions. The role requires the following physical activities and/or requirements:
    • Remaining stationary or seated for extended periods.
    • Performing repetitive motions, such as keyboarding, involving the wrists, hands, and/or fingers.
    • Communicating effectively with others.
    • Adjusting, moving, carrying, lifting, pushing, or pulling objects weighing up to 20 pounds.
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Meet Recruitment 2022. Meet Recruitment Ltd., Meet Recruitment Inc. and Meet Personalberatung GmbH are all subsidiaries of Meet Group (No. 13556131) a company registered in England and Wales at Irongate House, 22-30 Dukes Place, London, EC3A 7LP.
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