Junior Quality Assurance Specialist

2 weeks ago


Sunrise Manor, Nevada, United States Terumo Aortic Full time

Position Overview

As a Junior Quality Assurance Specialist at Terumo Aortic, you will play a vital role in enhancing the quality of our innovative medical solutions aimed at treating aortic diseases globally. Our organization is dedicated to providing cutting-edge surgical and endovascular technologies that cater to diverse patient anatomies.

With a workforce of over 1,250 dedicated professionals and state-of-the-art manufacturing facilities, we are committed to fostering an environment that encourages personal and professional growth. Each team member contributes significantly to our mission of improving patient outcomes in more than 100 countries.

Key Responsibilities

  • Assist in the planning and execution of receiving inspections and supplier evaluations.
  • Support investigations into product non-conformities and manage escalations as necessary.
  • Design and implement tools to facilitate incoming inspections.
  • Develop and validate methods to enhance inspection processes.
  • Create and execute test protocols and validation reports.
  • Ensure thorough execution of test method validations.
  • Contribute to the development and completion of component Failure Mode and Effects Analyses (FMEAs).
  • Analyze non-conformities and initiate Corrective and Preventive Actions (CAPA) when required.
  • Provide technical assistance to the Supplier Quality program.
  • Monitor the efficiency of receiving inspection processes and suggest improvements.

Quality Management System Requirements

Adhere to the company’s handbook and policy statements while maintaining awareness of the significance of your activities in achieving quality objectives. Ensure compliance with the Quality Management System (QMS) and maintain accurate records.

Health, Safety, and Environmental Responsibilities

Prioritize your health and safety, as well as that of your colleagues, and collaborate to address any Environmental Health and Safety concerns.

Qualifications

  • Strong written and verbal communication skills.
  • Ability to engage with all organizational levels.
  • Analytical skills for data compilation and analysis.
  • Proficiency in computer software, with SolidWorks experience preferred.
  • Ability to perform light lifting tasks.
  • Bachelor’s degree in engineering or science; no prior experience required.
  • Familiarity with Lean Manufacturing and Six Sigma methodologies is advantageous.
  • Understanding of quality system regulations such as 21CFR820 and ISO13485.
  • Self-motivated with the ability to manage multiple tasks effectively.

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