*DON’T SUBMIT UNLESS THE PERSON HAS FDA and ISO experience!*
This is a QA person who has worked in a regulatory/FDA environment. On the resume we should see experience like this: FDA and ISO compliance experience (esp. QSR, Part 11, and IEC 62304) *Job Title:* QA Tester *Location:* Maplewood, MN *Duration:* 6+ Months *Job Description:* • Working as part of a development team on a commercial hardware / software system • Development and execution of the full V&V lifecycle for application software products and medical device software • Evaluate software quality testing and automation processes and develop process changes that ensure highest software quality deliverables and improve testing cycle times • Support ongoing process and methodology (Agile Scrum) improvements • Documenting processes and procedures *Qualifications:* • Bachelor's degree or equivalent experience • 5+ years experience in Software Quality or related role • Experience with defect management tools • Skilled in software engineering methodologies, software quality documentation, V&V, and commercialization of software products • Excellent written and verbal communication skills. • Excellent typing skills and familiarity with Microsoft Office • Proven ability to plan, document and effectively execute projects • Ability to multi-task in a fast-paced environment • A knack for troubleshooting and problem solving • Ability to support multiple concurrent projects *Experience in the following is a plus:* • Experience with regulated software product quality assurance processes • FDA and ISO compliance experience (esp. QSR, Part 11, and IEC 62304) • Experience with Microsoft software product development tools including Visual Studio, Team Foundation Server, and Microsoft Test Manager • Experience with automated testing and simulation • Experience leading offshore testing resources • Agile Scrum methodology - Minimal work direction needed,highly skilled and knowledgeable to the position and provides best practicing sharing within work group. - Responsible for the core activities of the test effort, which involves conducting the necessary tests and logging the outcomes of that testing. - Identify the Target Test Items to be evaluated by the test effort. - Define the appropriate tests required and any associated Test Data. - Gather and manage the Test Data. Evaluate and log the outcome of each test cycle. - Identify the most appropriate implementation approach for a given test. - Set up and execute the tests. - Analyze and recover from execution errors. Thanks & Regards, *Ravi Teja* Technical Recruiter MSoftware Solutions Inc. Email: [email protected]
