Software Quality Assurance Professional

3 days ago


Naperville, Illinois, United States Endotronix, Inc Full time
About Us

Endotronix, Inc. is a leading medical device company dedicated to transforming the treatment of heart failure.

We are committed to providing innovative solutions that improve patient quality of life and reduce healthcare costs.

About the Role

We are seeking an experienced Software Quality Assurance Professional to join our team.

This key role involves executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout the product lifecycle.

The successful candidate will be responsible for developing and conducting training on the software development and validation program.

  • Develop in-depth knowledge of the entire software lifecycle for Endotronix products
  • Collaborate with cross-functional teams to establish product specifications, quality plans, and software development/deployment procedures
  • Review and approval of design verification and validation protocols and reports to ensure technical soundness and sufficiency
  • Participate in design reviews to ensure customer and regulatory requirements have been properly translated into design inputs
  • Encourage continuous improvement in design control activities and proactive utilization of quality tools with design teams

Key Responsibilities:

  • Perform root cause analysis of field and internal issues and implement corrective actions
  • Support suppliers and internal investigations on quality-related issues
  • Model a culture of quality within the company and guide employees in best quality practices
  • Design, implement, debug, and document test cases and scripts to ensure software meets business needs and complies with regulations
  • Update and optimize quality assurance software development procedures
About You

We are looking for a highly skilled and experienced Software Quality Assurance Professional who can hit the ground running.

The ideal candidate will possess a strong background in software quality engineering, FDA regulations, and IEC 62304 standards.

A bachelor's degree in engineering or a technical field is required, and ASQ CSQE certification is desired.

The successful candidate will be able to work in a fast-paced environment, collaborate with cross-functional teams, and communicate effectively at multiple levels.

What We Offer:

  • A competitive compensation package with estimated salary range $120,000 - $150,000 per year
  • Comprehensive benefits, including unlimited PTO and opportunities for professional growth and development
  • A dynamic and inclusive work environment that values diversity, equity, and inclusion


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