Requisition ID: 35549
Software Quality AnalystJOB SUMMARYWorks 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.
ESSENTIAL DUTIES- 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/ServiceMax.
- 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.
MINIMUM QUALIFICATION REQUIREMENTSEducationBachelor's degree in computer science or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
ExperienceMinimum 2 years of experience
Experience in validation of ERP, QMS/PLM, HRIS and CRM preferred.
Skills- 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.
PHYSICAL REQUIREMENTSTypical 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 this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties.
Target Pay Range: $91,600.00 to $114,600.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base: 7.0%
We anticipate this requisition will be open for a minimum of five days, from . We encourage your prompt application.
At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.
- Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
- In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue.
- We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
- We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
- Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
- Respect - Appreciative of others
- Integrity - Guided by our mission
- Care - Empathetic to patients
- Quality - Committed to excellence
- Creativity - Striving for innovation
- We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025.
