- Responsible for implementing best practices and company policies for software quality assurance directly contributing to quality deliverables for company software and services.
- Plan and execute System Development Life Cycle activities per the established Quality Management System methodologies.
- Review and approving various Software Development Life Cycle deliverables, change control, and resulting Objective Evidence to ensure adherence to the established company policies and regulatory requirements.
- Work with stakeholders and members of designated project teams to ensure that computerized systems that are used in support of regulated activities and/or business processes.
Skills and Experience:
Four-year college degree in an applicable Engineering discipline such as Electrical, Computer Science or Biomedical Engineering
Minimum six years of experience in software development, and/or systems validation in a regulatory environment, including experience in one or more of the following system types: process automation, enterprise systems, laboratory systems, spreadsheets, management dashboards, or quality systems.