Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Join our Quality team in Austin and help bring safe, reliable medical device innovations to life. As a Quality Engineer, you will be a key quality partner for new product development, working across functions to ensure products meet demanding quality, safety, performance and regulatory requirements. What will you be doing? Provide quality leadership for new product development project teams, serving as the Quality Engineering representative and partnering with cross functional teams. Generate, approve and manage design verification, design validation, sterilization validation, process validation, supplier qualification and test method activities. Develop protocols, capability studies and risk assessments to support product safety, reliability and overall risk management. Ensure compliance with applicable product standards and regulatory requirements, including cGMP, QSR, US FDA, ISO, IEC, UL, EN and EU MDR requirements. Support manufacturing operations with expertise in product requirements, inspection and test methods, root cause investigations and issue resolution. Partner with external laboratories and suppliers to communicate product and process requirements and assess capabilities. Support continuous improvement and compliance activities, including CAPA resolution and nonconformance investigations. Support Post Market Surveillance, Quality Management Reviews and internal and external audits or inspections. What will you need to be successful? A 4-year technical degree is required, a bachelor's degree in biomedical or mechanical engineering is highly preferred 2-5 years in the medical device industry Familiarity with process development and new product development is a plus. Experience with design verification and validation, process or sterilization validation, risk management, test methods, supplier qualification and investigation or CAPA activities. Working knowledge of relevant medical device regulations and standards, including US FDA, QSR, cGMP, ISO and EU MDR requirements 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. Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. 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.

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