QA Software Validation Engineer WFH at Medline Industries in Winnetka, IL

QA Software Validation Engineer Position is a WFH (work from home) opportunity. Candidate needs to be located in Chicagoland area or Southeast Wisconsin and able to commute into Northfield headquarters location when necessary. Perform validation of new software and changes to existing software which control processes and support the manufacturing divisions' product and service outputs. Review... functional requirements documentation; design test plans, write test cases, oversee test strategies and perform testing for assigned applications. Execute software test plans and recommend modifications. Under broad supervision, debug moderately complex or portions of software products through the use of systematic tests to develop, apply, and maintain quality standards for company products. Core focus will be to serve as the link between design, characterization and production test. Oversee, review, and maintain software validation area processes and procedures. Update operational documents as required for study implementations. Prepare protocols and reports for software validation work. Coordinate all validation activities through constant communication with affected departments and personnel. Perform study failure analysis as required; recommend solutions, document, and implement. Identify and recommend testing equipment for study and operational use. Train operational users as required. Develop user handling instructions as required. Evaluate ways to streamline and improve efficiencies in software validation and associated processes. Review quote packages (RFQ) to determine software validation effort and investment. Provide cost and timing estimates. Collaborate/partner with business analysts on testing options and strategies, including applicable regulatory requirements. Plan and conduct specification reviews, design assessments, and inspections of assigned products and requirements. Collect and organize the test requirements and data for all levels of testing. Develop and document test plans, specifications, procedures, and cases in order to verify correct functionality and design of the software. Design, develop, and implement software validation test strategy, test plans, test automation scripts, and test procedures to meet requirements. Coordinate the specification, procurement, and construction of test equipment as needed. Ensure capability and performance of all test equipment and tools. Troubleshoot test equipment and test setups and coordinate efforts to repair or update equipment, as needed. Negotiate start and completion dates for validation efforts, required equipment and supplies, and seek customer approval for plans and timing. Develop and execute manual and automated scripts for requirement validation, integration, regression, performance and usability testing. Create and maintain reusable test data scripts. Develop and issue software validation test reports. Execute software validation test procedures. Track, monitor, and report on defects during testing. Analyze and verify any issues discovered, log potential software defects into a defect tracking database, and review test data with team members. Create summary reports for all tests conducted and distribute as required. Archive all test procedures and data in the appropriate file archive system. Follow testing strategy and recommend process and work product improvements. Support, organize and participate in technical design reviews, peer reviews, team meetings, and process audits. Ensure closure of software validation issues. Supports users by developing documentation and assistance tools. Medline offers a business casual, entrepreneurial work environment with strong growth potential, a competitive compensation package, and a complete benefits package including medical/dental/vision/life insurance; 401(k) with company match. And much more! COVID-19 Vaccination Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law. Education Bachelor's degree in Engineering or Computer Science field. Relevant Work Experience At least 3 years of experience in engineering or software engineering. Experience must include: performing requirements review and analysis; test set-up and preparation; developing test plan; developing and executing test procedures; developing test automation scripts; developing test report. Experience applying knowledge of GMP, QSR, and ISO regulations governing medical device and pharmaceutical manufacturing. Additional Experience applying knowledge of standard concepts, practices, and procedures within software engineering. Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary. Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates. Experience in working through details of a problem, overcoming obstacles and reaching a positive and successful solution through mathematical or systematic operations. Willing to travel up to 10% of the time for business purposes (within state and out of state). Preferred Qualifications Education Bachelor's degree in engineering or computer science. Relevant Work Experience Experience in the medical device or pharmaceutical manufacturing industry. QA/test engineering experience. Software engineering experience. Certification / Licensure ASQ certified Software Quality Engineer or Quality Engineer. Salary Range: $80K -- $100K Minimum Qualification Software Development, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications