*Software Quality Assurance Engineer with medical device exp* *Location: Cleveland, OH*
*Duration: 12 Months * *Max Rate is $45/hr on CTC * *Send me your resume @ **[email protected] <[email protected]> * Key Responsibilities • Analyze requirements and ensure the requirements may be verified through some executable protocol • Develop and execute software verification protocols to ensure the system meets requirements and passes medical device quality standards • Analyze standards and develop protocols to verify compliance to those standards • Document test reports and manage documentation in accordance to the Medical Client QMS • Organizing software design reviews, code reviews, testing, audit software build process and resolution. • Manage bug resolution and software change control process • Manage processes and documentation towards risk management and determining the level of concern for software. • Develop automated test scripts to facilitate the fast verification of key software functions on a periodic basis • Ensure that development processes are followed according to design controls • Develop, maintain, and execute software verification and validation plans for a medical device • Assist in vendor audits and internal audits • Assist in completion of required software documents for regulatory submissions • Enforce software change control pre- and post-release Requirements • B.S. in an engineering discipline • 5 year experience as a product development engineer, quality or test engineer in a medical device company, under design controls • Previous experience as a quality or test engineer in a medical device company • Knowledge of FDA Quality System regulations • Knowledge of ISO and CE Mark requirements • Knowledge of automated software testing tools • Working knowledge of verifying applications in a Windows environment • Knowledge of defect tracking systems • Familiarity with all phases of the Software Lifecycle • Experience developing, and conducting complex, documented software validation. Thanks & Regards, *Raj Chouhan *|Sr Techincal Recruiter *Email: **[email protected]* <[email protected]> *Contact:** (770) 410-7770 Ext: 127* *CODEFORCE 360* ERP & IT Services / Consulting – Development – Staffing *[image: Description: Description: Description: Description: Description: Description: unnamed (1)][image: Description: Description: Description: Description: Description: Description: unnamed][image: Description: Description: Description: Description: Description: Inc5000-starburst]* -- You received this message because you are subscribed to the Google Groups "SAP BASIS" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/sap-basis. For more options, visit https://groups.google.com/d/optout.
