Sr. Software QA Test Engineer: TAC Worldwide

Key Areas:

• Knowledge of ISO & FDA requirements/Class III medical device
• Experience reviewing requirements, design documentation for completeness, testability, and usability
• Defect/Bug tracking and documentation experience
• Process development
• Test requirement/protocol review and development (alpha & numeric)
• Black/White box testing and documentation
• Design control experience
• Experience with traceability matrices
• Embedded Software Test development

Under the direction of the VP Regulatory & Quality, development and execution of software protocols and automated scripts or code for testing embedded software systems.

Review requirements, design documentation, and code to assess correctness, completeness, testability, and usability.

Perform automated and manual, black and white box testing. Set up test data and configure hardware for verification of software applications.

Determine the means to overcome technical problems. Analyze, report, and maintain documentation of test results, defect reports and requests for change.

Work on complex problems where analysis of data requires an in-depth evaluation of various factors.

Perform duties as defined in documented processes and procedures. Normally receives no instruction on routine work.

• ESSENTIAL DUTIES
  Develops and execute both manual and automated test protocols.
• Assists in determination of scope of work for complex tasks and helps to establish project test schedules. Responsible for adhering to project test schedules.
• Conduct black box, white box, regression, exploratory, and ad hoc testing on the actual product and in simulated environments.
• Submit clear and concise defect reports, regressing defect corrections, and enter requests for change to improve the usability of the product.
• Participates in code inspections, technical reviews, and design reviews.
• Work proactively with staff to determine the best strategy for project test coverage.
• Communicate test status, progress, problems and changes to team lead as well as functional management. Recommend options to resolve testing issues.
• Develop expert knowledge for testing products through training and use.
• Continue to develop software quality engineering knowledge through seminars, web sites, technical publications, and contact with members of profession at technical meetings.
• Keeps abreast of the basic requirements for compliance in own area of work, and complies with those requirements.
• Participates as required in training on Regulatory issues affecting own area of work.
• Present regulatory compliance questions/issues to the attention of management.
• Other projects as assigned.

EXPERIENCE REQUIREMENTS:

• Bachelor's degree in Computer Science or related technical discipline
• Minimum of 5 years experience in Software QA/Test as a black box tester preferably in a medical device company.
• Experience in a small start-up environment (required).
• Experience using defect management and configuration management tools.
• Extensive experience in testing complex software systems in the medical device domain.
• Knowledge of cGMP or equivalent regulations.
• Understanding of the Software Development Lifecycle. Experience with software testing tools and automation.
• Experience in both white box and black box testing.
• Experience in testing C/C++ programs and scripting languages.
• Strong conceptual, analytical, and problem-solving abilities required.
• Excellent written and verbal communication skills required.
• Knowledge of ISO 9001-2000, ISO 13485, CE, UL, IEC 60101 and FDA Quality System Regulation and Verification and Validation requirements preferred.
• Specific vision abilities include close and distance vision, depth perception, peripheral vision and ability to adjust focus.

ABOUT TAC WORLDWIDE COMPANIES - www.tacworldwide.com

For more than 38 years, professionals have trusted TAC Worldwide to match their job skills and deliver opportunities that complement their interests and personalities. We provide associates with benefits programs, online technical training, career counseling, and on-going HR support.

In addition, TAC Worldwide communicates with all associates throughout their work assignments and strives to find new and interesting opportunities on their behalf. TAC Worldwide is committed to finding you rewarding short-term and long-term job assignments that deliver your ideal mix of job flexibility and professional independence.

We align your technology expertise, interests, and personality with clients' needs to ensure that you have great relationships with co-workers, that your skills stay sharp, and your talent challenged.

You can experience a variety of industries, top companies, explore new opportunities for professional development — and be secure in the knowledge that we're always working to make your transition to your next assignment smooth and speedy.

We provide Contract Talent with:

• Highly competitive compensation
• Option to purchase health care benefits (not available in all states) with EAP (Employment Assistance Program)
• 401K Flexible spending account
• Direct deposit
• Weekly payroll
• Career development
• Long and short-term assignments locally, nationally, and worldwide Career development and certification programs