Senior Quality Engineer, Software

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)
  3. United States
Montvale, USA
Posting date: 25 Feb 2021

Proclinical is currently recruiting for a Senior Quality Engineer of Software for a leading medical device company located remotely. As the Senior Quality Engineer, you will assist and support the organization with computer system and software validation activities. 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.

Job 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.

Skills and Requirements:

  • 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

If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 646-779-7968 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.