Quality Engineer, Medical Device

Responsibilities

•In this role, the Quality Engineer provides quality leadership, governance, and engineering best practices to Medical Device software development, testing, and implementation

•The incumbent will provide quality leadership for software development projects involving design and coding, verification/validation testing, release, and post-market support

•They will partner with R&D, Regulatory, and Operations to establish consistency across product platforms, drive software engineering design improvements, and lead implementation of design control related strategies and objectives

•This role will drive harmonization and alignment of West software development methodologies and processes across product platforms, sites, and teams to ensure consistency and state-of-the-art Design History Files

•Provide Quality Engineering oversight and direction for multiple concurrent software development programs to ensure software and product compliance to all applicable regulatory and cGMP requirements

•Provide leadership on the software development process, testing/validation, and compilation of design related technical and engineering documentation

•Partner with R&D teams to implement strategic platform-software development approaches to the product and software development processes

Qualifications

•Minimum, Bachelor's degree in: Computer Science, Software Engineering, or related field

•Minimum 1 years of experience in software development environment with technical software engineering experiences (design, coding, testing)

Thanks

Suchi@vastekgroup.com