SR ENGINEER, QA

job title sr engineer, qa
autoreqid 93711br
job family quality assurance
job category full-time
job classification experienced/established
division abbott molecular diagnostics
shift first
relocation assistance none
overview
at abbott, we provide the perspectives and experience necessary to translate science into real solutions for patients in over 130 markets worldwide. we believe that diversity drives innovation,
eeo statement:
at abbott.
software develpoment life cycle (5-9 years).
skills/experience requirements basic qualifications:
knowledge of regultaions and standards affecting ivds and biologics.abbott is regarded as an employer of choice for our commitment to workplace excellence, il
employer of choice
through numerous local, national and international accolades, a. or b.s. in engineering or computer related field
certification requirements asq csqe or cqe prefrered
significant work activities & conditions continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
percent of travel 0 - 20 %
country united states
state/province illinois
site location des plaines.through our diverse healthcare businesses, we connect people and potential in ways that no other company can.000 employees are doing work that matters, today, abbott\'s nearly 90.
major responsibilities:
responsible for implementing and maintaining the effectiveness of the quailty sytsem.innovative thinkers who are passionate about the work they do, abbott employees are representative of the diversity of the patients we strive to serve every single day across the globe.evaluates the use of development and testing tools and the corresponding need for validation; supports the validation of tools by helping define validation requirements in addition to reviewing and approving development and testing tool deliverables. trained and experienced lead assessor in conducting external assesmsents preferred, oral and interpresonal sklils, must be famliiar with applciable us regulations (fda 21 cfr part 11, and 820), storng prolbem solivng techinques and well deveolped written.
job descrpition the sofwtare quality engnieer is resposnible for system supoprt for the development and maintneance of proudct sofwtare and/or firmware as well as instrument system hardware.quality system experience (1-2 years). auditing experience (1-2).
preferred qualifications:asq csqe or cqe preferred
education requirements b.
functions include :design control guidance; review and approval of system deliverables for software and hardware; evaluating regression analysis; in-process assessments throughout the development life-cycle; participation in design reviews; performing supplier evaluations of software/instrument suppliers (oems); monitoring, drawings and specifications; responsible for the instrument/software design history file, ivdd, assessing and reporting on product software/firmware quality and compliance status; guidance with applicable requirements such as the fda quality system regulation, and iso as they pertain to software/firmware development and management; review and approve instrument and software product labeling; review and approve engineering change notices.
engineer also aids the development organizations in the development of the software/instrument quality system. experience in regulated software environment. lead and grow, with challenging opportunities and work that makes a difference, our employees are given the tools to succeed.must be self directed and work well in a team environment, be able to work on multiple projects concurrently and meet commitments.
discover a world of opportunities at abbott.(2-3 years) project management experience (1-2 years). participates in the review and closure of software problem reports and impact assessments.