Senior Design Quality Engineer

Serve as the Design Quality representative for product support and lifecycle management activities, including product improvements, design changes, quality planning, investigations, and continuous quality enhancement initiatives

Lead risk management activities including risk assessments, FMEA development and maintenance, implementation of risk controls, risk reviews, and verification of effectiveness

Provide design quality oversight and approval for design verification and validation activities, sterilization validations, process validations, supplier qualifications, manufacturing process changes, and test methods

Lead or support investigations related to complaints, nonconformances, CAPAs, post market surveillance, trend analysis, and product risk assessments to identify root causes and drive corrective and preventive actions

Review and approve quality and engineering documentation to ensure compliance with design controls, change control, risk management, and quality system requirements

Partner closely with Regulatory Affairs, Operations, R&D, Manufacturing, Marketing, Clinical, and Supplier Quality teams to support regulatory submissions, audits, inspections, and ongoing product support

Act as a quality engineering resource for complex technical and compliance related issues, providing guidance and influencing decisions that impact product quality, patient safety, and business objectives

Identify and drive continuous improvement opportunities through analysis of quality data, product feedback, risk management outputs, and operational performance metrics

Provide technical leadership, training, guidance, and mentorship to support effective decision making, accountability, compliance, and quality excellence

Bachelor of Science degree in Engineering or a technically related field

5+ years of experience in the medical device industry or another highly regulated environment

Strong knowledge of FDA QSR, ISO 13485, and ISO 14971 requirements

Experience with risk management, design controls, change control, CAPA, validation activities, and product lifecycle management

Demonstrated ability to solve complex quality challenges and influence cross functional stakeholders

Excellent communication, collaboration, and problem solving skills

CQE and/or Six Sigma certification preferred

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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