Senior Quality Engineer

Smith & Nephew; Pittsburgh (Allegheny County); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Paid Holidays

Health Insurance

Job summary

Smith & Nephew is seeking a Senior Design Quality Assurance Engineer to partner with cross-functional development teams and ensure quality, safety, and regulatory compliance of medical devices and software throughout the product lifecycle.

You will lead QA activities for new product development and design changes, perform risk assessments, and mentor teams on risk management and design control best practices. This hybrid role supports audits and quality system tooling across the organization.

Qualifications

• 4+ years of experience in quality assurance, software testing, automation, or software development; or 6+ years; or 8+ years.
• Experience applying ISO 13485, ISO 14971, IEC 62304.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820).
• Experience with software verification and validation activities.

Responsibilities

• Lead Design Quality Assurance activities for new product development and design change projects.
• Complete product risk assessments, including FMEAs and other risk management activities.
• Review/approve design inputs, specifications, and traceability documents.
• Review/approve software unit tests and support integration, verification and validation testing activities.
• Complete CSV and CSA activities for Quality System tools.
• Support audits, CAPAs, non-conformances, and compliance investigations.
• Mentor teams on SDLC, risk management, and design control compliance.

Skills

Quality Assurance

Software Testing

Risk Management

Traceability

Unit Testing

Integration Testing

Regression Testing

Automated Testing

Design Reviews

Communication

Education

Bachelor's degree

Master's degree

Associate degree

Tools

Linux

Angular

React CLI

Jest

SpecFlow

Cucumber

Jasmine

JUnit

NUnit

Job description

Life Unlimited. At Smith+Nap
hwe design and manufacture technology that takes the limits off living. Are you passionate about software quality, risk management, and medical device compliance? We are looking for a Senior Design Quality Assurance Engineer to partner with cross-functional development teams and ensure the quality, safety, and regulatory compliance of medical devices and software applications throughout the product lifecycle. This position plays a key role in new product development and design change projects, providing quality leadership, risk management expertise, and guidance on software validation, verification, and regulatory compliance.

What will you be doing?

Lead Design Quality Assurance activities for new product development and design change projects. Complete and facilitate product risk assessments, including FMEAs and other risk management activities. Review and approve design input requirements, specifications, and traceability documentation. Review and approve software unit tests and support integration, verification, and validation testing activities. Complete Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for Quality System tools. Support audits, CAPAs, non-conformances, and compliance investigations as required. Mentor engineering teams on software development lifecycle best practices, risk management, and design control compliance.

What will you need to be successful?

Required Qualifications

Bachelors or Masters Degree or Associate Degree & Experience in a degree/program or related discipline with 4+ years of experience in quality assurance, software testing, automation, or software development; OR 6+ years relevant experience; OR 8+ years relevant experience. Technical Knowledge strong understanding of Design Quality Assurance principles, including design requirements and specifications, risk assessments and risk management, requirements traceability, unit, integration, and regression testing, automated testing methodologies, design and code reviews. Experience applying ISO 13485, ISO 14971, and IEC 62304. Experience working within regulated industries, preferably medical devices. Knowledge of FDA Quality System requirements, including 21 CFR Part 820 and Quality Management System Regulations. Experience supporting software verification and validation activities. Ability to work effectively with geographically dispersed and cross-functional teams. Strong analytical, problem-solving, and communication skills. Ability to work independently with minimal supervision.

Preferred Qualifications

Software Quality Engineer Certification. Experience with Agile development methodologies, including SAFe. Experience developing and executing manual and automated test suites. Experience with BDD/TDD methodologies. Experience with Linux environments. Experience with Angular, React CLI, Jest, SpecFlow, Cucumber, Jasmine, JUnit, or NUnit. Experience testing mobile applications on iOS and Android platforms. Experience working with multiple programming languages and software development environments.

You Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/). Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program Training: Hands-On, Team-Customized, Mentorship Extra Perks: Discounts on fitness clubs, travel and more! #LI-HYBRID #LI-MA1 Smith+Nap
Smith+Nap ensures you have the rich professional performing packaging step to bring back patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nap a unique place. Yes we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.