Software Quality Analyst

Location: Lakewood, US

At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.
For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.
Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference.
Join us and help shape wherever we go next. You create your future and ours.

Works under general supervision by providing technical expertise in an area of software validation activities to include testing. Performs a range of tasks which may include analysis, evaluation, testing, and documentation.

• Operates somewhat independently in executing validation testing and documentation activities per the program policy and procedure for the company Quality Management System and Product Lifecycle Management Systems.
• Develops user requirements/functional requirements, test plans, test procedures, and test scripts based on system and software requirements.
• Become well versed in testing global enterprise applications for SAP ERP, QMS/PLM Windchill, SAP Successfactors and CRM Salesforce/Service Max.
• Work with team members to deliver on time validated software code to production.
• Requires demonstrated ability to analyze problems of varying levels and then design and implement solutions.

Bachelor’s degree in computer science or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Minimum 2 years of experience

Experience in validation of ERP, QMS/PLM, HRIS and CRM preferred.

• Requires flexibility to adapt to and a willingness to learn new technologies.
• Familiarity with GMP/GAMP V/IEEE/ISO 9000 standards for software quality assurance, impact/risk analysis, and software traceability.
• Strong with documentation; writing sound user and functional requirements documents, validation summary reports, validation test scripts and deviation documents
• Demonstrate a strong voice in group settings to maintain program integrity
• Must be able to manage deadlines
• Must be very detail oriented in following all aspects of the validation program and ensuring all completed validation packages are audit ready. This is a key to success
• Capability to implement a process discipline and maintain departmental productivity.
• Ability to perform business analyst duties to assist with requirements gathering responsibilities is a plus
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge in applicable regulatory life science regulations (FDA CFR Part 11)

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of…