Systems/Software Verification Test Engineer
Concord , CA 94518
Posted 7 days ago
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Are you interested in working with the largest independent software testing company? Read on!
QualiTest is looking for System/Software Verification Test Engineer's in Concord, CA to join our rapidly expanding teams!
- Coordinate and communicate between V&V team and other departments
- Compose reports and make adjustments to equipment or processes that require improvement
- Responsible for assuring projects meet customer expectations, and regulatory requirements
- Provide guidance to engineering staff and other personnel and ensure that design control requirements and being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review
- Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF for accuracy and completeness and provide guidance on FDA compliance and procedures
- Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards
- Assist in the development and maintenance of company procedures for design control, change management, risk management, test method validation, process validation and related areas of the quality management system
- Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices
- Perform white box testing on medical device systems.
- Bachelors or Masters in Computer Science, Software Engineering, Biomedical Engineering or related field required
- MUST have experience with medical device testing (dialysis experience highly preferred)
- MUST have experience with systems level testing
- MUST have experience with white/black box testing
- Thorough understanding of FDA Quality System regulations in relation to computer system validation
- Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements
- Ability to multi-task and operate within a fast-paced environment
- Excellent oral, written, analytical, computer and interpersonal skills
- Functional Testing Experience
- Proactive Individual who is self-motivated and confident
- Have continuous access to and work with Senior Testing Specialists and Practice Experts
- Be a part of a leading testing company, globally recognized as a Visionary by Gartner Magic Quadrant
- Work with cutting edge technology in a company built by testers for testers, this is what we do!
- As a global company, we offer unique placement opportunities around the world
- Our QualiTesters are the reason for our success, we constantly encourage career development and promote from within
Intrigued to find more about us?
If you like what you have read, send us your resume and lets start talking!