- 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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Skills Required
- 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 requirements
- Strong knowledge of ISO 13485 requirements
- Strong knowledge of ISO 14971 requirements
- Experience with risk management, design controls, change control, CAPA, validation activities, and product lifecycle management
- Ability to solve complex quality challenges and influence cross-functional stakeholders
- Excellent communication, collaboration, and problem-solving skills
- CQE and/or Six Sigma certification
Smith & Nephew Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Smith & Nephew and has not been reviewed or approved by Smith & Nephew.
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Healthcare Strength — Medical, dental, and vision plans are paired with a global mental‑health program for employees and families, indicating a robust core health package.
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Retirement Support — U.S. employees have access to a 401(k) with company contributions, and share plans complement long‑term savings.
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Leave & Time Off Breadth — Generous holiday, paid volunteering leave, and flexible work models point to broad time‑off options.
Smith & Nephew Insights
What We Do
Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their 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+Nephew 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, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited. Please note: not all products referred to may be approved for use or available in all markets.
