Design Quality Engineer

• Bachelor of Science degree in Engineering or a related technical discipline.
• Minimum of 2 years of experience in the medical device industry or another regulated environment.
• Working knowledge of: FDA Quality System Regulations (QSR) ISO 13485 ISO 14971 Design Controls Risk Management methodologies CAPA and complaint handling processes
• Strong analytical, communication, collaboration, and problem-solving skills.
• Ability to develop and implement solutions to complex quality challenges.

• Certified Quality Engineer (CQE).
• Six Sigma certification.
• Experience supporting sustaining engineering and product lifecycle management.
• Experience participating in audits, inspections, and regulatory submissions.

Physical Demands

• Primarily seated work with occasional light lifting.

Travel Requirements

• Less than 10% travel.

• Support product lifecycle management activities, including design changes, product improvements, investigations, and quality plans.
• Lead and support risk management activities, including risk assessments, FMEAs, implementation of risk controls, and effectiveness reviews.
• Review and approve design verification and validation activities, manufacturing process changes, supplier qualifications, and process validations.
• Investigate complaints, nonconformances, CAPAs, post-market surveillance trends, and product risk assessments to identify root causes and drive corrective actions.
• Ensure compliance with Design Controls, Change Control, Risk Management, and Quality System requirements throughout the product lifecycle.
• Collaborate with Regulatory Affairs, R&D, Manufacturing, Operations, Clinical, Marketing, and Supplier Quality teams to support product quality and regulatory compliance.
• Provide technical quality guidance and influence decisions that impact product performance, compliance, and patient safety.
• Drive continuous improvement initiatives using quality metrics, post-market data, and operational performance insights.

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!  

The anticipated base compensation range for this position is $74,250 to $111,500 USD annually. ​The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew.

In addition to base pay, we offer competitive bonus and benefits, including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays, 8 hours of volunteer time annually, and a variety of wellness offerings such as EAP.

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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.