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This position is responsible for Product Software Quality Engineering activities, including those related to non-product software used in the product development process, which includes quality system and process software. The position works within the Design Control, Production and Process Controls, Risk Management elements of the Quality System, and is responsible for ensuring all software is developed and implemented to meet the requirements of worldwide regulatory requirements. This involves managing the Software Quality Engineers, possibly assigned to multiple locations, ensuring effective cross-functional software control processes.

1. Maintain and follow proper compliance and quality systems requirements.
2. Manage the Product Software Quality Engineering resources.
3. Establish and maintain procedures and infrastructure needed to manage the Product Software Quality system.
4. Monitor worldwide industry standards and upgrade the Software Quality system to assure ongoing compliance.
5. Provide technical assistance and leadership required to plan and implement software projects to be completed, including organizing and leading members of various departments, planning and scheduling, coordinating resources, preparing proper documentation, etc. in a manner consistent with company objectives.
6. Represent the Software Quality Engineering organization in a cross-functional manner by providing engineering expertise to develop new products or improve existing products/processes and implement software solutions for engineering problems.
7. Maintain current knowledge of competitive technologies in medical, biomedical, and other technical developments related to company products.

Requires Bachelor of Science degree and a minimum of 8 years of experience in GMP software management within a regulated manufacturing environment. Experience and knowledge in software validation tools and industry standards.

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