Software Quality Assurance Specialist

Responsibilities:

• The candidate is responsible for all software quality assurance activities such as evaluation of software lifecycle (SLC) deliverables for compliance with Operating Procedures, FDA requirements and the CFR including 21 CFR Part 11.
• Lead or participate in various reviews, risk analyses and other software quality assurance activities with primary focus on review and approval of restrictions, configurations, and validation supporting documents.
• Have a background in software engineering, software lifecycle activities, or software validation and be familiar with the work products that result from SLC key activities.
• Knowledge or experience in requirements gathering, analysis techniques, software verification/validation techniques, configuration management techniques or documentation standards.
• The candidate should be familiar with IEEE, SEI, ISO and have experience in a regulated environment. Analytical and troubleshooting skills are important, as is the ability to manage tasks. Must be able to manage multiple tasks and resources.
• Support project teams in planning, preparation, reviewing and approval of quality documents. Create quality system documentation with guidance from technical teams following approved templates and guidelines.
• Collect and compile key quality metric data.
• Assist with processing configuration and restriction implementation within SAP S4 HANA enterprise system.
• Ability to maintain a high degree of accuracy and analytical thinking.
• Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and suggest improvements within our quality system.
• Assist in the design of effective quality systems, procedures and/or processes to ensure compliance as well as efficiency throughout our quality system.
• Good verbal and written communication skills. Knowledge or experience in computerize system validation/testing; SAP S4 HANA and Trackwise preferred.

Requirements:

• Minimum Bachelor's degree, background in software engineering or software quality assurance, Engineering or other technical/ scientific area or equivalent experience.
• 4-7 YEARS EXPERIENCE
• Hands-on professional with experience in the software lifecycle (SLC).