Software Quality Assurance Analyst (SQA)
-Must have Medical Device FDA experience
-Create software hazard analysis (SHA), product and software requirements (PRD, SRD), software design specification (PSD) and trace ability documents for Design Control for multiple projects
-Prepare documents for and assist with iteration planning, defect review, protocol and report writing, provide technical support to test team and outside partners, technical writers
- Software DHF Management, Risk Management and Change Management
-Adhere to company specific Software Development Life Cycle Process
-Knowledge of IEC62304: 2006
- Create User Requirements, review and train contractor on hazard analysis, and write user work instructions for validating the DOORS application
-Hold workshops to develop and refine specifications and requirements
-Hold Design Review meetings at project milestones
-Self motivated and able to work independently
SDED Global works with companies that need to be FDA compliant. We provide solutions in Audits, Compliance, Software Development, Training and Validation, We accomplish this by working with client systems and remediation for any components that may be at risk. Our experts take a risk-based approach, doing what's right to ensure our clients are compliant by making certain they understand what needs to be accomplished. Our growing business has over 23 years of experience in excellence.
No man, woman or child should EVER suffer as a result of an adulterated or failed medical device. At SDED Global, it is our passion to ensure that this statement is fulfilled. SDED Global is a Medical Device Compliance Consulting firm that drives clients to excellence ensuring safe and effective medical devices domestically and internationally.
The CEO has worked in the medical device industry for 24+ years. Her education in biochemistry, began at the bench in Research/Development and led to experience in many areas of the industry from Quality to Software Development and Validation. She became integrated in what it took to confirm that a product adhered to the standards and regulations for various submissions. She thrived in this area. It is not only the goal of SDED Global, but her personal mantra, to not only adhere to but surpass global regulations and standards.
At SDED Global, we evaluate Client needs and customize the required strategy and solution to provide high Quality Compliance Consulting that is Efficient, Innovative, Analytical, Deliverable and first to market. We offer the best customer experience and empower our clients with skill sets to maintain a defend-able product. We not only meet their immediate needs we teach and guide all throughout the processes. This approach allows us to demonstrate what is required to sustain their long-term goals.
South San Francisco, CA
Fri, 18 Aug 2017 11:39:33 PDT