*REPLY TO [email protected]** * *Hi, *
* Software Quality Assurance Engineer* *9 Month Contract* *Location: San Francisco, area* * * * * *REQUIREMENTS:* *Candidate must have a minimum of 5 years medical device experience* *Ability to work in teams with all levels of management.* *Our client is seeking a Senior Software Quality Engineer to work on site in the Bay area of California. This role requires SWQE to become an integral member of the project team, develop Verification Test Plans, associated verification procedures, protocols and reports to assure overall regulatory compliance to the QSR, and applicable Quality System standards.* *The primary role of Software Quality Engineering (SWQE) is to ensure that Software, as part of Medical Device development, is in accordance with good design practices, and Design Control requirements defined by the FDA Code of Federal Regulations, Volume 21, Section 820 (QSR). Executing this role requires SWQE to become an integral member of the project team, develop Verification Test Plans, associated verification procedures, protocols and reports to assure overall regulatory compliance to the QSR, and applicable Quality System standards.* * * * RESPONSIBILITIES: Participates in the development of Project Plans Collaborates in Hazard / Risk Assessment and contributes to the Risk Analysis / Risk Management Report Provides design team support for determination of applicable safety agency requirements Provides design team with medical device regulatory input Participates in generating or generates Product Requirement Specifications as directed by the project manager Creates, approves, releases and implements best practices for QE documentation Participates in Design and Phase Reviews Generates verification test plans, procedures, protocols, reports and trace matrices providing evidence that the design meets requirement specifications Provide client with safety agency and regulatory approval support when requested* * * *Thanks and Regards Tom BeyondTekIT Tel: 714-857-2002 - Ext -819 Fax: 714-364-9705 [email protected] www.beyondtekit.com* ** --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "Oracle-Distribution" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [email protected] For more options, visit this group at http://groups.google.com/group/Oracle-Distribution -~----------~----~----~----~------~----~------~--~---
