Software Quality Assurance Engineer II

Position Summary:

This position supports the Research and Development Software Quality Engineering team with the verification and validation of new products being developed. This person designs and executes test plans and hazard and safety analyses per the specifications, adhering to all policies and procedures. They ensure outcomes are measured, data is tracked accurately, and proper documentation meets all compliance requirements. This person support projects as needed.

Position Responsibilities:

Responsible for (but not limited to) the following:

• Supports routine design verification of new product design and development of the resultant design along with process compliance to regulatory requirements.
• Develops moderate-complex schedules/resource plans for the testing portion of a project.
• Designs and executes test plans\procedures.
• Documents and delivers all test results, analysis, and test summary reports to the appropriate repository.
• Provides clear scope definition, implements new tools, drives change management, and defines metrics that define successful completion.
• Represents customer perspective in project quality decisions.
• Supports Regulatory agency audits and inspections testing assignments on updates to existing products.
• Duties may include activities to support the customer complaint process.
• Duties may include audit activities.

Required Skills & Education:

• Bachelor's degree in any STEM degree and minimum two years of Software QA experience (or HS Diploma/GED and a minimum of seven years of Software QA experience).
• Demonstrated data-driven decision making.
• Ability to influence within peer group and higher management.
• Excellent attention to detail.
• Leadership skills.
• Strong analytical, decision-making, and critical thinking skills. Excellent written and verbal communication.

Desired Skills:

• Quality Engineering, manufacturing, or service experience within an ISO and/or FDA regulated medical device industry.
• Proficient in the use of statistical software (ex. Minitab, Reliasoft, etc).
• Demonstrated knowledge with various automation tools/environments/languages including but not limited to Robot Framework, GIT, AzDO, Python, Java, Fish/Eye/Crucible, Ghost.
• Quality Certification (CMST, CSM, CSQE, CSTE, CTFL).
• Green Belt Certification or Six Sigma Black Belt.
• Competent in the use of quality tools (ex. Reliability, FMEA, fault tree analysis, root cause analysis, fishbone diagrams, DOE, ANOVA, Cpk, etc).