Senior Quality Engineer

Smith Nephew; Pittsburgh (Allegheny County); Hybrid; USD 110,000 - 145,000; Full time

Benefits offered by this job

401k Matching

Tuition Reimbursement

Health Insurance

Paid Holidays

Parental Leave

Job summary

Smith+ Nephew in United States (Pittsburgh area) seeks a Senior Design Quality Assurance Engineer to partner with cross-functional teams, ensuring quality, safety, and regulatory compliance for medical devices and software across the lifecycle.

The role emphasizes design quality, risk management, and CSV/CSA activities, with mentorship to peers and involvement in audits and investigations.

Qualifications

• Master's or bachelor's or associate degree with related QA/engineering experience.
• Strong understanding of Design Quality Assurance principles and risk management.
• Experience applying ISO 13485, ISO 14971, and IEC 62304.
• Familiarity with FDA QSR 21 CFR Part 820 and Quality System Regulations.
• Experience supporting software verification and validation.

Responsibilities

• Lead Design QA activities for new product development and design changes.
• Conduct product risk assessments including FMEA and risk management activities.
• Review and approve design inputs, specifications, and traceability.
• Review and approve software unit tests; support integration, verification, and validation.
• Execute CSV and CSA activities for Quality System tools.
• Support audits, CAPAs, non-conformances, and investigations as needed.
• Mentor engineering teams on SDLC best practices, risk management, and design control compliance.

Skills

Quality Assurance

Risk management

Regulatory compliance

Software validation

Cross-functional collaboration

Mentoring

Education

Master's Degree in Engineering, Computer Science, or related

Bachelor's Degree in Engineering, Computer Science, or related

Associate Degree with 8+ years experience

Tools

Angular

React

Jest

SpecFlow

Cucumber

JUnit

NUnit

Linux

Job description

Life Unlimited.

At Smith+ Nephew, we 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

Education & Experience

• Master's Degree in Engineering, Computer Science, or related discipline with 4+ years of experience in quality assurance, software testing, automation, or software development; OR
• Bachelor's Degree in Engineering, Computer Science, or related discipline with 6+ years of relevant experience; OR
• Associate Degree with 8+ years of 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!

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Smith+ Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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