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Senior Quality Engineer, Software

Company: Loves Furniture
Location: Montvale
Posted on: February 22, 2021

Job Description:

Position: Senior Quality Engineer, Software Location: Montvale, NJ
Job Id: 2021-01-002 # of Openings: 1 Summary The Senior Quality Engineer, Software will assist and support the organization with computer system and software validation activities. This includes performing assessments of computer systems and software processes currently being used or to be used at PENTAX Medical Montvale, NJ facility within a QMS or GxP process; 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. The ability to liaise with IT, QARA, Operations, R&D, vendors and other stakeholders to agreed schedule, support, and resources is crucial to providing timely implementation and a successful go-live of validated systems and applications.-- Responsibilities

  • 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. Minimum Qualifications
    • 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 It is the ongoing policy and practice of PENTAX Medical to provide equal opportunity in employment to all employees and applicants. No person shall be discriminated against in any condition of employment because of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law.

Keywords: Loves Furniture, Yonkers , Senior Quality Engineer, Software, IT / Software / Systems , Montvale, New York

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