Quality Assurance Manager

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
Bring your quality leadership and medical device expertise to a role where you will help shape the design quality of new and existing Orthopaedics products. Based in Memphis, you will lead the NPD Design Quality Engineering team, partnering across functions to support successful product launches, effective risk management and robust design controls.
What will you be doing?
Lead the Memphis NPD Design Quality Engineering team, providing quality leadership across Trauma, Extremities and other Orthopaedics programs.
Partner with cross functional teams throughout new product development to support rigorous design quality, risk management, design controls and compliant design history files.
Oversee quality engineering activities to ensure appropriate risk mitigations, inspection methods and good engineering practices are incorporated into new products and processes.
Support manufacturing operations with expertise in product requirements, risk management, test methods and statistical analysis, including internally and externally manufactured products.
Support post market product risk assessments and the maintenance of risk management processes, files and outcomes.
Champion lean and effective design control processes while supporting compliance with applicable cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD and MDR requirements.
Support and sustain elements of the Quality System through procedure development, training, auditing and technical support, while establishing project schedules and reporting on progress.
What will you need to be successful?
Bachelor’s degree in Mechanical, Biomedical, Packaging or a related Engineering discipline, with 6 to 8 years of experience in the medical device industry or another regulated field.
Strong knowledge of design quality, new product development, risk management, design controls, manufacturing quality and applicable regulatory and quality requirements.
Demonstrated ability to lead quality engineers and collaborate effectively with global and cross functional teams, production associates and external suppliers.
Effective written and verbal communication, project management and time management skills, with the ability to work independently and collaboratively.
Proficiency with Microsoft Word, Excel, PowerPoint, MS Project, Visio and Minitab, plus the ability to lift 30 lbs. and sit or stand for extended periods.
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.
Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, 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
Flexibility: Hybrid Work Model (For most professional roles)
Training: Hands-On, Team-Customized, Mentorship
Extra Perks: Discounts on fitness clubs, travel and more!
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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