Software Quality Engineering (SQE) Manager

Terumo Blood and Cell Technologies; Lakewood (CO); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Terumo Blood and Cell Technologies is seeking an experienced Software Quality Engineering (SQE) Manager to lead a team of SQEs and drive a shift-left, risk-based quality program across new product development and sustaining products.

In this hands-on leadership role, you will own test strategies, collaborate with Software Development, Systems Engineering, and DevOps, and ensure regulatory compliance, traceability, and continuous verification across global projects.

Qualifications

• Experience in test strategy development and risk-based testing.
• Understanding of the software development lifecycle and shift-left practices.
• Ability to design repeatable, traceable test cases and coverage.
• Knowledge of software quality standards and regulatory compliance.
• Strong collaboration across software, systems engineering, and DevOps.
• Familiarity with AI-assisted development and modern QA tools.

Responsibilities

• Lead and coach a team of SQEs, delivering high performance and development.
• Contribute hands-on to test design, reviews, and quality activities on projects.
• Define, review, and approve test cases aligned to strategy and regulatory needs.
• Develop high-quality manual and automated test cases with proper coverage.
• Drive adherence to SQE processes, gates, and lifecycle expectations.
• Partner with Dev, Systems, and DevOps to embed shift-left and continuous testing.
• Support architecture reviews to ensure testability and early quality validation.
• Operate cybersecurity and performance testing strategies within projects.
• Drive continuous improvement of SQE processes based on metrics and feedback.

Skills

Test strategy development

Risk-based testing

SDET integration

Software lifecycle understanding

Shift-left quality

Cross-functional collaboration

Regulatory compliance knowledge

Root cause analysis

Leadership

Global distributed teams

Education

Bachelor's degree in Computer Science, Engineering, or equivalent

Tools

Automation frameworks

Job description

Software Quality Engineering (SQE) Manager

JOB SUMMARY

The Software Quality Engineering (SQE) Manager is a key leader within the Software Quality Engineering organization responsible for ensuring the delivery of secure, compliant, and high-quality software across both new product development and sustaining products. This role leads a team of SQEs while actively contributing as a hands‑on engineer, driving the execution and continuous improvement of a modern, shift‑left, and continuous quality engineering model.

The SQE Manager owns the implementation of test strategy and ensures that all test design aligns to risk, requirements, and regulatory expectations. This role maintains strong partnership with Software Development, Systems Engineering, DevOps, and global teams to ensure quality is embedded early in the lifecycle and sustained through continuous verification and feedback.

A critical focus of this role is enforcing disciplined processes, ensuring high-quality, repeatable, and traceable test design, and driving alignment to the global SQE operating model. The SQE Manager plays a key role in coaching and developing SQE capability while ensuring consistent execution of quality practices across projects and sites.

ESSENTIAL DUTIES

• Lead and manage a team of SQEs, providing coaching, performance management, and professional development to build a high-performing organization.
• Execute as a working manager by contributing directly to test design, review, and quality engineering activities across active projects.
• Ensure test cases are defined, reviewed, and approved in alignment with overall test strategy, risk, and regulatory requirements.
• Develop and oversee the creation of high-quality test cases for both manual and automated testing, ensuring appropriate coverage and traceability. Determine and guide which test cases should be automated versus remain manual, based on risk, repeatability, efficiency, and overall value.
• Drive development of comprehensive, repeatable, and traceable test cases that fully cover product requirements and risk controls.
• Enforce adherence to defined SQE processes, quality gates, and lifecycle expectations to prevent defect escape and reduce rework.
• Partner with Software Development, Systems Engineering, and DevOps to embed shift‑left practices and continuous testing into development workflows.
• Participate in architecture and design reviews to ensure testability, early quality validation, and alignment with system requirements.
• Support and operationalize cybersecurity and performance testing strategies within project execution and test design.
• Review test execution results and ensure accuracy, completeness, and appropriate defect identification.
• Drive continuous improvement of SQE processes, tools, and practices based on project insights, metrics, and feedback.
• Ensure global consistency in test practices, enabling test cases to be executed reliably across distributed teams with defined baseline knowledge.
• Reinforce alignment to the SQE ownership model, ensuring test strategy remains SQE-driven and automation execution aligns with defined test cases.

OTHER DUTIES AND RESPONSIBILITIES

• Support the Senior SQE Manager in defining and evolving global SQE strategy, processes, and standards.
• Promote adoption of standard methodologies, tools, and best practices across teams and sites.
• Provide input to organizational capability development, training, and upskilling initiatives.
• Ensure compliance with medical device regulatory standards through strong documentation, traceability, and verification practices.

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 8 years experience.

• Experience in a software quality engineering role with proven understanding of all phases of the development lifecycle including scoping, design, construction, integration and testing.
• Experience in regulated environments (e.g., medical devices, aerospace) preferred.

Skills

• Strong expertise in test strategy development, risk-based testing, and requirements coverage
• Deep understanding of the software development lifecycle and shift‑left quality practices
• Ability to design and evaluate high-quality, repeatable, and traceable test cases
• Experience with software quality standards, regulatory compliance, and traceability expectations
• Strong collaboration skills across Software Development, Systems Engineering, and DevOps
• Knowledge of automation frameworks and understanding of SDET integration into test strategy
• Familiarity with AI-assisted development and modern quality engineering tools
• Ability to enforce disciplined processes, quality gates, and execution consistency
• Strong analytical and problem-solving skills, including root cause analysis and defect evaluation
• Effective communication and leadership skills, with the ability to influence cross‑functional teams
• Experience working in global, distributed team environments
• Commitment to continuous improvement, learning, and adoption of evolving engineering practices

-Or-

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

PHYSICAL REQUIREMENTS

Hybrid position reporting to the Lakewood, CO headquarters a minimum of 3 days a week.

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.