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.
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.
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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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