Software Quality Engineer - Katalyst Healthcares & Life Sciences
Lake Forest, IL 60035
About the Job
Responsibilities and Requirements:
- Software Quality Engineer.
- Experience in Software Quality Assurance and hands on software validation experience.
- Experience in regulated industry needed: Pharma or Med device.
- Experience in ISO13495, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA Computer System Assurance.
- Complete validation of the software which includes creating and identifying all deliverables starting from Risk classification requirements, design development, testing test protocols, OQ/OQ, traceability matrix and summary documents.
- There will be coordination needed with multiple teams. So, they must be able to communicate clearly and identify the risks proactively. They must raise the requests wherever there is potential of issue and delay that may impact the project deliverable in timely completion.
- Must have experience working in a matrixed environment.
- FDA submission experience will be a plus.
- Non-Pharma, non-health care, automobiles, and telecom experience will not be considered.
- Experience in product software space will be given preference over the non-product software.
Source : Katalyst Healthcares & Life Sciences
