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Quality Engineer ! Contract | Irvine, CA (onsite)

Trinus
Irvine, CA Full Time
POSTED ON 2/13/2025
AVAILABLE BEFORE 5/13/2025

Job Description

Job Description

We are seeking a Quality Engineer to apply quality engineering principles to ensure regulatory compliance and optimize device manufacturing and distribution processes. This role will also support pre-commercial device builds and product releases.

Key Responsibilities :

  • Support areas such as Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD).
  • Lead or assist in test method development / validation for Design Verification testing and manufacturing inspections.
  • Investigate complex manufacturing quality issues, determine root causes, and initiate corrective actions.
  • Contribute to design and development activities, including feasibility testing and drawing review.
  • Participate in Project Risk Assessments (PRA) and escalation tasks.
  • Collaborate with R&D and Manufacturing to ensure successful execution of NPD and product launches.
  • Develop and execute experiments to improve products and manufacturing processes.
  • Maintain risk management files and technical documentation.
  • Develop training and work instructions for production teams to ensure seamless knowledge transfer.
  • Supervise technicians, provide training, and oversee manufacturing support tasks.
  • Travel up to 10% domestically and internationally.

Required Qualifications :

  • Bachelor's degree in engineering or related field with at least 2 years of experience in NPD, Quality Engineering, R&D, or Manufacturing; or a Master's degree with relevant internship or project experience.
  • Experience in a highly regulated industry.
  • Preferred Qualifications :

  • Experience in medical devices or related healthcare fields.
  • Knowledge of Design Assurance, Design Verification & Validation, and Process Validation.
  • Experience with root cause analysis, investigations, and NPD from concept to commercialization.
  • Proficiency in MS Office Suite, including MS Project.
  • Strong problem-solving, analytical, and organizational skills.
  • Trinus Corporation, a leading provider of technology solutions and services with over 25 years of experience, is a certified WBE / MBE / SBE / SDB firm accredited by WBENC, NMSDC, and SBA.

    Our mission is to shape the future of work by aligning the right mix of people, process, technology, and innovation to efficiently meet our clients' business objectives.

    At Trinus, we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit.

    To learn more about us, please visit our website www.trinus.com

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