Mgr Eng Software Qual Assurance

Requisition ID: 33231

At Terumo Blood and Cell Technologies, our 7,000+ 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 Assurance Manager

JOB SUMMARY

Leads and drives quality excellence across our software product portfolio, including medical devices with embedded software and associated data management applications. This role combines strategic leadership with hands-on technical expertise to transform testing processes and build high-performing quality assurance teams. The position requires deep expertise in modern quality assurance methodologies, regulatory compliance, and risk management in medical device software development. The successful candidate will champion a culture of quality throughout the product development lifecycle while ensuring compliance with global regulatory requirements and industry standards. They will drive continuous improvement initiatives that enhance software reliability, testing efficiency, and overall product quality.

ESSENTIAL DUTIES

• Lead and mentor a global Software Quality Assurance team, fostering a culture of excellence and continuous improvement while developing team capabilities and effectiveness
• Define and implement comprehensive quality assurance strategies aligned with business objectives and regulatory requirements across multiple concurrent product releases
• Drive the evolution of testing processes, including automation frameworks, continuous integration/continuous delivery (CI/CD) pipelines, and quality metrics programs
• Collaborate with cross-functional teams to integrate quality practices throughout the software development lifecycle, from requirements through deployment
• Establish and maintain quality management systems that ensure compliance with FDA, ISO, and other relevant regulatory standards for medical device software
• Develop and oversee risk management strategies, including safety analysis, verification protocols, and validation frameworks for medical device software
• Lead quality governance activities, including internal audits, external regulatory inspections, and quality system effectiveness reviews
• Drive the adoption of modern testing methodologies and tools, including test automation, performance testing, and security testing
• Manage resource allocation, budgeting, and capacity planning across multiple projects while ensuring optimal team performance
• Partner with product management and development teams to define quality acceptance criteria and testing strategies for new features and products
• Establish metrics and KPIs to measure and improve quality processes, team performance, and product quality outcomes
• Create and maintain quality documentation, including test plans, validation protocols, and regulatory submissions
• Lead incident management and root cause analysis processes, implementing corrective actions to prevent recurrence

Represent quality assurance in key product decisions and strategic planning initiatives

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor's degree in Computer Science, Engineering, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Experience

Minimum 10 years experience

• Experience preferred in the SQA field with proven understanding of all phases of the development lifecycle including scoping, design, construction, integration and testing.

• Previous experience in a regulated environment with ability to interpret and incorporate into software quality industry standards preferred.

Skills

• Comprehensive knowledge of software testing methodologies, including test automation, performance testing, and security testing
• Deep understanding of medical device software regulations (FDA, ISO 13485, IEC 62304) and quality system requirements
• Proven experience with modern ALM tools (PTC Codebeamer), CI/CD pipelines, and test automation frameworks
• Strong background in risk management methodologies and their application in medical device software development
• Experience with embedded systems testing, including Linux-based systems and real-time operating systems
• Proficiency with container technologies (Docker, Kubernetes) and cloud-based testing environments preferred
• Demonstrated success in building and leading high-performing global quality assurance teams
• Strong analytical and problem-solving skills with ability to make data-driven decisions
• Experience with agile development methodologies and quality practices in agile environments
• Excellent project management skills with ability to manage multiple concurrent projects
• Strong communication skills with ability to influence cross-functional teams and senior leadership
• Track record of implementing process improvements that enhance efficiency and quality outcomes
• Experience with modern testing tools, issue tracking systems, and quality management systems

-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 accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:$124,200.00to$155,300.00 -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:15.0%

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 of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 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 $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.