Sr. SW Validation Quality Engineer
Acton, MA

Job Description

Position Summary

This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for IT Systems initiatives and for automated data processing systems used as part of the quality system. This includes ensuring that the IT Software Systems and Tools are compliant with applicable standards, regulations and guidance documents for medical devices and GxP computerized systems. This role will interface with other Insulet departments (e.g. Information Technology, Manufacturing, Management, Operations, Engineering, and Regulatory Affairs) as well as vendors and other external parties on issues related to IT Systems, Tools, and Product Development, and software used for automation of the quality system. The ability to effectively communicate software and design and development regulatory requirements, optimize the development process, and ensure ambiguities and conflicting requirements are resolved are critical to the success of the position.

Responsibilities

* Quality Lead for Design Assurance of IT GxP and non-GxP systems ensuring compliance to applicable regulations including ISO 13485, FDA Quality System Regulation 21 CFR Part 820 and General Principles of Software Validation.
* Review requirements, specifications, design documents, validation plans and reports user acceptance protocols, test plans, test cases, traceability matrices and other documentation as required and provide timely feedback.
* Assist with the execution of validation testing for new and updated computerized systems that are used as part of production processes or in the quality system.
* Experience with Design Control and Software Development initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices, mobile applications, cloud based systems, and cybersecurity.
* Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements.
* Provide guidance for the generation, review and approval of design control documentation with primary focus on software development deliverables.
* Collaborate with Project Management to support and optimize the Design Control and SW Development Processes.
* Support development teams on the validation of software tools.
* Work with software, hardware, user experience, marketing, manufacturing, and quality assurance on generation, documentation, verification and validation of requirements.
* Lead creation of necessary documentation to comply with regulatory requirements and industry best practices.
* Establish and maintain software quality assurance programs, processes, procedures and controls to ensure compliance with FDA regulations and established standards such as IEC 62304
* Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation
* Provide guidance on, and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management
* Applies a good working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements and agencies as it relates to Quality Assurance activities in software development. Maintain effective communication with the project software engineers to make sure that user needs, requirements, plans, verification and validation documents, risk assessments, and other documentation is complete.

Education and Experience

* ASQ, CSQE or other software quality certificates are beneficial.
* BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience. Master's degree preferred.
* Experience with medical device software development.
* Experience with a risk-based approach to validate computerized systems, Commercial off the Shelf (COTS) software and SW Tools.
* Experience with software mobile applications, cloud based systems, and cybersecurity.
* A minimum of 5 years work experience in Software Quality Engineering within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
* Experience in the development and implementation of effective Design Control Systems.
* Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.
* Working knowledge of IEC 62304, ISO 14971, and FDA guidance documents on software development, cybersecurity, and submission requirements for PMA and 510(k).
* Demonstrated experience organizing and maintaining large documentation sets.
* Experience with structured phase-gate product development processes.
* Familiarity with GAMP 5 guidance.
* Experience with software design V&V, computerized systems validations, and process validations.
* Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
* Experience with software development lifecycles with emphasis on the software quality engineering aspects.

Skills/Competencies:

* Effective verbal and written communication skills.
* Experience collaborating and communicate with individuals at multiple levels in an
* Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
* Strong analytical and problem-solving skills.
* Able to work effectively in a high-stress, high-energy environment.
* Ability to manage people and projects in a fast-moving environment.