Precise Solutions Senior Software Quality Assurance Engineer in Waukegan, Illinois
Precise Solutions is an Illinois BEP/FBE (female owned business enterprise) certified consulting company founded in 2000. Our mission is to provide companies with specialized resources that can drive their system portfolio projects using program management processes, change management and blended learning solutions. Please visit our website at www.precise-solutions.com
At Precise Solutions, we are looking for top talent consultants to bring on as employees of our organization and service our clients in the pharmaceutical and healthcare industries primarily located in the Northern Chicago Suburbs. We are much more than a consulting firm! Precise Solutions provides competitive compensation packages with great salaries, benefits, health insurance, paid time off and pension. We currently have an immediate need for the following:
Senior Quality Assurance Engineer
10+ YEARS OF EXPERIENCE IN THE FOLLOWING:
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.
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 skills are important, as is the ability to manage tasks.
Must be able to manage multiple tasks and resources.
Good with verbal and written communication skills.
Minimum Bachelors degree, background in software engineering or software quality assurance.
Hands-on professional with experience in the software lifecycle (SLC).
NOTES FROM MANAGER:
This is a Quality Engineer role in which they will be reviewing and approving, NOT creating
Needs to have quality assurance experience where they were able to ensure compliance with regulations (sox, cfr21, etc)