» Software Quality Control Engineer
| TITLE |
|
SQC Engineer (Software Quality Control Engineer) |
| POSITION |
|
Write and execute test plans, test cases and requirements trace matrices conforming with FDA regulations and governing laws (21 CFR Part 11, 203 and PDMA) for Web-based applications being developed for MedManage’s FDA-regulated organization. Responsible for feature and product quality control across multiple releases; driving test plan and test case reviews; functional, integration, system and performance testing using manual and automated tools; creation of test-web environments; review of Functional Specifications and Technical Design Documents from the software quality assurance perspective to mitigate risk and ensure that features are fully defined; and writing T-SQL queries. |
| REQUIRES |
|
- Bachelor of Science Degree in Computer Science or Computer Information Systems, or the foreign degree equivalent; and,
- Two years of experience in quality assurance and testing of Web-based applications. Must include design and execution of test plans and test cases to perform manual, functional, integration, system, and performance testing against internal and third-party applications, including the creation of test-web environments by installing, configuring and maintaining multiple virtual environments (VM Ware); reading and writing T-SQL queries (Microsoft SQL Server); and use of PVCS Tracker, TFS, and Test Director 9.0. Also requires specific experience with FDA regulations and governing laws (21 CFR Part 11, 203 and PDMA) and with IQs, SOPs, requirements traceability matrices, and computer systems validation protocols.
|
| LOCATION |
|
40 hours per week in Bothell, WA. |
| RESUMES |
|
Julie Orr
MedManage Systems, Inc.
3303 Monte Villa Parkway, Suite 325
Bothell, WA 98021
ATTN: Job #0844
|
» Senior Validation Engineer
| TITLE |
|
Sr. Validation Engineer |
| POSITION |
|
Ensure and document the company’s compliance with FDA regulations as it relates to the prescription drug industry including computer system validation activities. Define and formalize the company’s validation processes; create Validation deliverables; review and ultimately approve company documents for compliance with FDA Regulations; and work with software developers and testers to determine validation efforts needed. |
| REQUIRES |
|
- Master’s Degree in Biomedical Engineering, Life Sciences or a related field, or the foreign degree equivalent; and,
- Two years of experience in validation and software testing. Must include interpretation of pharmaceutical industry sampling FDA regulations and governing laws (21 CFR Part 11, 203 and PDMA ) and lead validation testing in conformance with above regulations. Must also include specific experience with Validation Plans including IQ, OQ and PQ protocols, SOPs, Validation Summary Reports, Requirements Traceability matrices, deviation reports and change controls; and project management including scheduling, risk monitoring and mitigation.
|
| LOCATION |
|
40 hours per week in Bothell, WA. |
| RESUMES |
|
Julie Orr
MedManage Systems, Inc.
3303 Monte Villa Parkway, Suite 325
Bothell, WA 98021
ATTN: Job #0849
|
|