Senior Quality Assurance Engineer

2 weeks ago


Fremont, California, United States Indotronix Avani Group Full time

Position: Quality Engineer III

Company: Indotronix Avani Group

Job Overview:

The Quality Engineer III will be responsible for developing, executing, and reviewing comprehensive testing strategies and protocols to guarantee that medical device and equipment products adhere to stringent quality benchmarks. This role involves overseeing product quality throughout the complete design and development lifecycle. Collaboration with research and development teams is essential to facilitate new product innovation and enhance existing product designs. Additionally, the engineer will investigate any quality discrepancies and recommend necessary modifications.

Key Responsibilities:

  • Lead and support new product development initiatives, ensuring compliance with internal quality management systems and relevant ISO, FDA, IVDR, and QSR regulations.
  • Ensure that appropriate design controls are in place during design review sessions.
  • Provide operational insights regarding quality challenges, including process enhancements and updates to risk assessments (DFMEA & PFMEA).
  • Oversee pre- and post-production quality assurance activities related to product lifecycle management.
  • Review and authorize validation protocols and reports, collaborating with Supplier Quality and Supply Chain teams to develop effective product suppliers.
  • Confirm that configuration management and risk analysis documentation are accurately maintained and addressed.
  • Examine test protocols and final reports for thoroughness and precision.
  • Ensure that design modifications are processed according to established change-control protocols.
  • Lead and assist in CAPA investigations, including reviews, approvals, and implementation of CAPA plans as needed.

Qualifications:

  • A Bachelor's degree coupled with a minimum of 7 years of experience in medical device quality assurance.
  • Proven experience in product and process validation, software validation (supporting both device and quality systems), test method validation, statistics, risk management tools, and process control & monitoring (SPC).
  • Ability to analyze trends and data, translating findings into actionable improvements.
  • Proficiency in Microsoft Office Suite.
  • 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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