QA Validation Analyst
(2 positions available)Requires a four-year college degree in an applicable Engineering discipline such as Electrical, Computer Science or Biomedical Engineering and a minimum of four years of experience in software development, and/or systems validation in a regulatory environment, including experience with one or more of the following system types: process automation, enterprise systems, laboratory systems, spreadsheets, management dashboards, or quality systems.
This position is responsible for providing Software Quality Assurance (SQA) engineering support for all lifecycle phases of computerized systems. The scope of the SQA Engineer II responsibility includes all software applications used in activities that support Quality System Regulations, except for software that is part of medical devices. The role includes implementing and enforcing company policies and procedures for software quality assurance directly contributing to quality deliverables.
Responsibilities:
1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
2. Enforce the company’s Quality Standards and Procedures for Computerized Systems, as defined in the company’s governing Quality Management System.
3. Participate in the validation of Computerized Systems such as, but not limited to, Enterprise Software, Crystal Reports, Automated Equipment, Regulated Spreadsheets, Medical Device Test Fixtures, and R&D Systems.
4. Help implement risk-based System Validation, Process Validation, and Software Validation.
5. Provide interpretation and guidance on various SDLC methodologies.
6. Participate in department quality improvement initiatives and actively apply software QA methodology standards.
7 Directly support QA initiatives for planned and unplanned software releases.
8. Create, maintain, summarize, review, and approve QA related-documentation against quality-document attributes, including but not limited to good documentation practices, completeness, traceability, accuracy, coverage and testability of system requirements, software defect detection, compliance risk mitigation, change management, roles and responsibilities.
9. Collaborate with Product and project management teams on system-related enhancements as well as issue resolution.
10. Review business and technical designs, mock-ups, and other work products for new functionality/features and provide feedback as needed.
11. Demonstrate a broad knowledge of business system architectures, including but not limited to: Web, Mainframe, Client-Server, Mobile, and Software-as-Service.
12. Proactively escalate issues and risks appropriately through proper channels.
13. Perform other duties as assigned.
If interested in above position, please send an email with your updated profile to "info@synergysoftwaresolutions.com".
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