Position Overview

Quality Engineering, Validations - Intern

The Quality Engineering, Validations Intern supports the quality engineering activities related to development and manufacture of medical devices. The intern will work with engineers to assist on various projects. Typical job duties might include:

  • Support sterilization validation projects for E-beam, ethylene oxide (EtO) with guidance from subject matter experts. This may include, but is not limited to:

  • Test protocol generation, process challenge device (PCD) assembly, sterilization validation cycle processing, temperature mapping, coordination of microbiological testing with internal and external laboratories.

  • Support software validation projects for manufacturing equipment software and non-equipment software systems with guidance from subject matter experts. This may include, but is not limited to:

  • Partner with process owners to develop software requirements/specifications, risk analyses, test case and test protocols, traceability matrices, software validation execution, and validation test reports

  • Support projects related to environmental monitoring of clean rooms, in order to ensure compliance to regulations with regards to the specified limits.

  • Update procedures and complete test report write-ups

  • Support a dynamic team and performs other duties as assigned.

The Quality Assurance group manages, performs, and verifies work affecting the quality of products and processes. Quality Assurance partners with various departments to strive for operational excellence with focus on total integrated quality.

  • Required Qualifications

    • Working toward a Bachelor or Master’s degree in Biology, Mechanical Engineering, Biomedical Engineering or other related discipline.

    • Ability to read, write, and follow detailed procedures

    • Demonstrated experience reading & preparing technical documentation, such as procedures and test reports

    • Attention to detail

    • Ability to accurately complete tasks in timely manner, and communicate any challenges or questions

    • Computer experience and skills including MS Word & Excel.

    • Ability to present clear and concise information to individuals or groups

    Desired Qualifications

    • Strong analytical capability and organization skills.

    • Good interpersonal and communication skills and the ability to work effectively in a team environment and autonomously.

    • Knowledge of medical device industry

    Additional Information

    • This will be a hybrid model position, with at least 60% of time spent at company headquarters in Aliso Viejo, CA. This may vary week-to-week based on project needs.

    • Candidates must be eligible to work in the U.S. and not require visa sponsorship.

    • Relocation may be available for qualified candidates.

    • For more information, visit our web site at www.microvention.com