The Senior Software Quality Engineer is responsible for providing leadership in quality, governance, and engineering best practices in the development, testing, and implementation of medical device software. They will oversee multiple projects to ensure regulatory and quality compliance is maintained throughout the software and product development cycle. The role involves providing quality leadership for software development projects from design and coding to verification/validation testing, release, and post-market support.
It is the responsibility of the incumbent to ensure that products meet quality standards according to internal procedures and acceptance criteria, as well as all design control and regulatory requirements for the intended distributed markets. They will collaborate with R&D, Regulatory, and Operations teams to establish consistency across product platforms, drive software engineering design improvements, and lead the implementation of design control related strategies and objectives.
The Senior Software Quality Engineer will ensure that the company's software development methodologies and processes are harmonized and aligned across product platforms, sites, and teams to ensure consistency and state-of-the-art Design History Files. They will act as a strong advocate for software quality at all stages of product realization and identify and implement improvements within the Enterprise Quality Management System as part of the company's continual improvement and global objectives.
- Exhibit a strong "quality first" mentality and ensure that software and product quality are held to the highest standard.
- 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.
- Author, review, and/or approve software-related documentation (e.g., strategic planning, requirements, specifications, verification & validation activities, risk management activities, protocols, reports, etc.).
- Provide quality oversight, review, and approval of software documentation and reports. Provide direction during technical and design review activities as a Software Quality SME. Provide Quality oversight of software related verification/validation/design controls activities to other QEs. Review the quality of work completed with the project team to ensure it meets project standards.
- Lead the development and maintenance of software risk analysis in accordance with the company's policies and procedures.
- Lead and support software engineering through all stages of the software product lifecycle for medical devices (Design, Verification and Validation Testing, Release, and Post-Market).
- Support cybersecurity team in conducting security review, updating and maintaining security policy and procedure to meet relevant industry standards and regulations (HIPAA, GDPR, HITRUST, etc.).
- Supports internal and third-party audits on the software documentation and development processes.
- Authors and/or reviews reports by collecting, analyzing, and summarizing data; implements corrective actions where necessary as determined by trended data analyses. Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
- Drive a harmonized design control program globally within the enterprise with the support of Design Quality leadership. Author and review product development related QMS procedures and work instructions. Proactively identify potential gaps and lead projects to resolve them.
- Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services and processes, including the company's QMS.
- Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, etc. Provide leadership and direct input on any nonconformance, deviation, or excursion that may occur and drive to closure.
- Establish routine communication strategies for project tracking and prioritization.
- Drive continuous quality improvement projects.
- Other duties as assigned.