Quality Assurance Engineer

2 weeks ago


Fremont, California, United States Integration International Inc. Full time

Position: Quality Assurance Engineer

Company: Integration International Inc.

Job Overview:

We are seeking a dedicated Quality Assurance Engineer to join our team. This role involves overseeing and supporting the development of new products while ensuring compliance with our internal quality management system and relevant regulations.

Key Responsibilities:

  • Oversee and assist in the new product development process, ensuring compliance with ISO, FDA, IVDR, and QSR standards.
  • Facilitate design reviews to confirm that appropriate design controls are in place.
  • Collaborate with operations to address quality concerns, including process enhancements and updates to risk assessments (DFMEA & PFMEA).
  • Provide essential quality engineering support for necessary investigations.
  • Coordinate the resolution of any quality assurance issues identified during the product realization phase.
  • Lead and assist in CAPA investigations, including reviews, approvals, and implementation of CAPA plans as needed.

Qualifications:

  • A Bachelor’s degree accompanied by at least 7 years of experience in quality assurance within the medical device sector.
  • Strong interpersonal abilities, demonstrating a collaborative spirit and professionalism within the team and across departments.
  • Proven experience in product and process validation, software validation, test method validation, and risk management tools.
  • Exceptional documentation skills, with a keen focus on process orientation and attention to detail.
  • Self-motivated and independent thinker, capable of working autonomously.
  • Quality engineering certification (ASQ CQE or CQA) is preferred.
  • Familiarity with lean six sigma manufacturing methodologies.
  • Additional training in lean processes, such as green belt certification, is advantageous.


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