Quality Engineer, Medical Device

2 weeks ago

Dallas, United States Vastek, Inc. Full time
Job DescriptionJob Description

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

 

Company DescriptionVastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.Company DescriptionVastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.

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