Design Quality Engineer
Smith+Nephew
Summary
Join Smith+Nephew as a Design Quality Engineer and play a key role in supporting our Sports Medicine Joint Repair portfolio while helping improve outcomes for patients around the world. As a Design Quality Engineer, you will partner with cross-functional teams to support sustaining engineering and lifecycle management activities, ensuring products continue to meet quality, regulatory, and business requirements.
Job description
What will you be doing?
- 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.
What will you need to be successful?
Required Qualifications
- 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.
Preferred Qualifications
- Certified Quality Engineer (CQE).
- Six Sigma certification.
- Experience supporting sustaining engineering and product lifecycle management.
- Experience participating in audits, inspections, and regulatory submissions.
Requirements
- 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)
- Working knowledge of ISO 13485
- Working knowledge of ISO 14971
- Working knowledge of Design Controls
- Working knowledge of Risk Management methodologies
- Working knowledge of CAPA and complaint handling processes
- Strong analytical, communication, collaboration, and problem-solving skills
- Ability to develop and implement solutions to complex quality challenges
Benefits
- 401(k) Matching
- 401(k) Plus Program
- Discounted Stock Options
- Tuition Reimbursement
- Flexible PTO
- Paid Holidays
- Flex Holidays
- Paid Community Service Day
- Medical, Dental & Vision
- Health Savings Account
- Employee Assistance Program
- Parental Leave
- Fertility & Adoption Assistance
- Fitness Club Discounts
Company overview
Smith+Nephew is a global portfolio medical technology company with a rich history dating back to 1856, originally founded as a chemist shop in Hull, UK. The company specializes in the repair, regeneration, and replacement of soft and hard tissue through innovative medical devices and technologies. Operating through three core business units—Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management—Smith+Nephew serves healthcare professionals and patients in over 100 countries worldwide. With approximately 18,000 employees, the company generated annual sales of $5.5 billion in 2023 and is listed on both the London Stock Exchange (FTSE100) and New York Stock Exchange. Their product portfolio includes joint replacement systems, robotics-assisted surgical platforms, sports medicine implants, advanced wound care solutions, and ENT technologies. The company is pioneering new frontiers in medical technology, including Spatial Surgery systems that integrate augmented reality and real-time data processing for enhanced surgical precision. Smith+Nephew's mission centers on their "Life Unlimited" purpose, aiming to restore patients' bodies and self-belief through technological innovation that removes limitations on living.