The Software Quality Validation Engineer provides design quality engineering support to the design and development group for software development and design changes in support of Moogs infusion and enteral feeding pumps sold both in the US and internationally. This individual will have a critical role in fostering overall quality and ensuring compliance with regulatory requirements and international standards with respect to quality system, manufacturing, and medical device software.

·       Approve and support design, software and processes verification and validation protocols including code review.

·       Review and support compliance for quality systems requirements.

·       Identify compliance gaps and work with Engineering team to resolve compliance issues.

·       Identify improvement opportunities within the company Quality Management System (QMS)

·       Support cross-functional projects to improve and maintain compliant, effective and efficient quality processes.

·       Maintain up-to-date knowledge of regulatory requirements, international standards, and company QMS procedures for areas of responsibility.

·       Perform and/or support risk management activities.

·       RA/QA representative on design reviews.

·       Perform/Document audit, classify observations, review audit with audited.

·       Other projects as assigned by management.

·       Bachelors degree in Engineering/ Computer Science/ Quality Assurance or a closely related discipline.

·       QA or engineering/development experience in a regulated industry.

·       Working knowledge of regulatory requirements and international standards such as FDA Quality System.

·       Knowledge of Medical Device Directive and Regulation, ISO 13485, ISO 14971, IEC 62304 would be considered as beneficial.

·       Knowledge in at least one of the following programming languages: C++, C#, Python.

·       Software development experience would be considered as beneficial.

·       Experience in automated testing techniques and tools would be considered as beneficial.

·       Strong interpersonal and communication skills (technical, non-technical, and cross-cultural).

·       Excellent knowledge of Lithuanian and English (both written and oral).

·       Attention to details and ability to consistently meet high standards of quality.

·       Good organization and time-management skills, and ability to work simultaneously on multiple projects.

·       Proficiency using Microsoft Office tools: Word, Excel, Power Point and Outlook.

·       Understanding of risk management principles and practices.

·       Experience in collection and analysis of quality metrics.

·       Working knowledge of statistical methods.