Senior Quality Engineer - Northern NJ - Direct Hire
Job Title: Senior Quality Engineer
Status: Direct Hire Remote: No - Onsite Required in Northern NJ
We are currently seeking a Senior Quality Engineer, Software who will assist and support the organization with computer system and software validation activities. In this role, you will be responsible for performing assessments of computer systems and software processes within a regulated environment; compiling and maintaining the Validation Master Plan and procedures; as well as assisting functional/business owner in creating and executing the require system or software validation plans, documentation and tests.
Qualified candidates should be able to work with various business groups in order to support and provide timely implementation and a successful go-live of validated systems and applications.
Perform assessments of current non-device computer systems, applications and software and their related processes.
Maintain the site’s Validation Master Plan and report in recurring status and review meetings.
Prepare computer and software validation documents including validation plans, user and functional requirements, configuration specifications, test protocols, and reports.
Support cross functional organization’s quality and GxP business needs and translate into user and functional requirements.
Develop, maintain and update work instructions and procedures to define computer system validation standards, templates and processes.
Bachelor’s degree in Engineering, Life Sciences or a related field (Masters preferred)
Minimum of 5 years’ Computer System or Software Validation experience in an FDA and/or ISO regulated environment
Thorough understanding of FDA 21CFR 820 and ISO 13485 regulations
Thorough understanding of software system verification/validation methodology
Working knowledge and understanding of Good Automation Manufacturing Practices (GAMP)
Experiencing in creating test protocols including IQs/OQs/PQs
Understanding of SDLC and IT/System change management processes
Project management experience in a regulated environment, preferably medical device, pharmaceutical, or health science as part of an interdisciplinary team
Excellent problem solving, technical writing, and communication skills
Must be self-motivated and detailed oriented
ASQ Certified Software Quality Engineer (CSQE) or Certified Quality Engineer (CQE) certification a plus