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Medical Equipment Manufacturing

Senior SQA Engineer

Natick, Massachusetts, United StatesOnsiteFull TimeSenior$120,000–$130,000 /yrPosted 4 days agoVisa sponsorship available

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Role summary

The Senior SQA Engineer is a senior-level role focused on testing and verifying complex medical device software to ensure it meets quality, regulatory, and user needs. Responsibilities include documenting verification procedures and results, creating and executing test scripts, setting up testing environments, and collaborating with the software engineering team. The role may involve automating verification processes and mentoring junior SQA engineers. A strong understanding of software quality, attention to detail, and analytical problem-solving skills are essential.

Position Title: Senior SQA Engineer Department: Product Development

Reports To: Principal SQA Engineer/Tech Lead FLSA: exempt

GENERAL SUMMARY

*Senior SQA Engineer is a senior-level position that involves the testing and verification of complex software solutions to ensure they meet quality standards. This role identifies software defects and contributes to the delivery of high-quality products that meet the needs of the intended use of our products as well as the quality and regulatory expectations for medical device development and production.*

ESSENTIAL JOB FUNCTIONS

  • *Participate in verification, testing, and documentation of medical device software per governing SOPs*
  • *Document verification procedures, verification results and traceability matrices.*
  • *Develop solid understanding of the medical device software products*
  • *Document testing methodologies, along with defect tracking and reporting.*
  • *Create, execute, and maintain test scripts for use within projects and regression testing.*
  • *Set up and maintain testing environments for different testing needs*
  • *Work closely with the software engineering team in all phases of the development cycle.*
  • *May work on automating verification procedures to achieve test automation of the medical device software products*
  • *Mentor more junior SQA engineers and conduct technical training for the SQA engineering team.*

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# OTHER DUTIES AND RESPONSIBILITIES

  • *Additional responsibilities may or may not be assigned to the employee; role assignment will be reviewed on a case-by-case basis determinant upon individual strengths, experience, knowledge, and expertise.*

# PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

  • *5-10 years of experience with a bachelor’s degree, 3-7 years of experience with a master’s degree, or 1-5 years of experience with a PhD degree in mathematics, computer science, engineering, or related field from a 4-year college or university.*
  • *3-5 years’ experience in software testing of medical device software.*
  • *Strong understanding of test automation is a plus.*
  • *Good testing knowledge and experience of software applications.*
  • *Good knowledge of QA process development and testing experience with software that has a hardware component is a plus.*
  • *A strong sense of software quality and attention to details.*
  • *Excellent written and verbal communication skills.*
  • *Strong analytical problem solving skills.*
  • *Ability to mentor staff*
  • *Ability to work successfully in various sizes of teams or independently to meet project deadlines.*
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