Software Quality Analyst

Requisition : 34629

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.

Software Quality Analyst

JOB SUMMARY

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.

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 very well versed in the Windchill application and able to navigate its functionalities
• 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 REQUIREMENTS

Education

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.

Experience

Minimum 2 years of experience

Experience in validation of PTC Windchill V 11 or 12 is a definite plus

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 REQUIREMENTS

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 this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:$85,600.00to$
-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%

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…