Software Quality Engineer

• Extensive experience in a Software Quality Assurance (SQA), Computer System Validation (CSV) or similar role, supporting an Enterprise Heath care, Medical Device, Life science, etc., type environment
• Extensive experience supporting a portfolio and variety of Validated Systems (i.e. ServiceNow, Document Mgmt., Learning Mgmt., ERP, MES, etc.)
• Expert/SME knowledge of CFR Part 11 and the relevant Software Lifecycle -- FDA QSR, ISO guidelines
• Strong experience with ALM, Mfiles
• Strong communication experience -- requirement gathering, stakeholder mgmt.
  
  

Job Description

Client is looking to hire a Senior Software Quality Assurance Engineer . You will ensure that product software and computerized systems used in the support of the Quality System are developed, validated, and maintained in compliance with applicable regulatory and corporate requirements. They will participate as a member of the project team for a variety of Software products that incorporate software/firmware into their system – this could be Document Mgmt., Learning Mgmt., ERP, Manufacturing Execution, Inventory Mgmt., Complaints and other similar systems. This person will review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of the software or firmware. They will coordinate activities with other engineering disciplines, departments and contractors. Estimate, plan and review own and others' work products.

What You’ll Do

• Completes SQA tasks in accordance with current Quality System Requirements.
• Works independently with objectives given by SWQA Manager or QA Director.
• Can plan and coordinate own work according to higher-level project schedules.
• Reviews pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan.
• Ensure documentation accuracy, clarity, consistency, completeness, and compliance for multiple projects. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports.
• Report unexpected events, issues or software bugs which occur during verification/validation to project team and management.
• Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of computerized systems used in the Quality System as well as those used in the development of ADC Abbott and Lingo software/firmware products.
• Ensures that appropriate procedures, controls, and disaster recovery plans are incorporated into new computerized systems.
• May Develop and maintain Validation Master Plan(s).
• May have responsibilities to monitor and direct the work of contractors/temporaries.
• Ensure that Abbott and Lingo computerized systems used in the support of the Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements.
• Ensure that deliverables and activities are in compliance with current Software/SWQA processes in the development of Lingo software/firmware products.
  
  

Additional Skills & Qualifications

• Abbott experience
• CFR 820 and relevant CFR regulations
  
  

Employee Value Proposition (EVP)

• Long term contract -- majority of contractors have been on-site 2+ years
• Growing life sciences industry
• highly respected Fortune 100 organization
  
  

Work Environment

• fast paced, complex, high expectations -- must be very detail oriented
  
  

Business Drivers/Customer Impact

• new projects -- growing application presence in Corp IT for Nutrition and Med Device BUs