Design Quality Engineer (Austin, TX)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

The Design Quality Engineer 1 will implement, support, and sustain elements of Smith & Nephew's Quality System through procedure generation, training, auditing, and technical support. The Design Quality Engineer 1 determines methods, techniques, and evaluation criteria for medical devices and will serve as a key resource for regulations and standard requirements.

**This position does not offer any type of visa sponsorship now or in the future**

What will you be doing?

• (50%) Provide quality leadership to project teams as the quality engineering representative. Work with a cross-functional team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications/standards and that the safety and reliability of products are established. Generate/approve/manage design verification, design validations, sterilization validations, process validations, supplier qualifications, test methods with supporting protocols, capability studies, and risk assessments as part of overall risk management.

• (25%) Support manufacturing operations and provide expertise in product requirements, inspection/test methods, root cause investigation/resolution and interface with internal stakeholders.

• (10%) Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and EU-MDR requirements. Ensure that all responsibilities within the scope of this job comply with the scope of the Quality System.

• (5%) Work with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier.

• (5%) Support continuous improvement and compliance activities such as CAPA resolution and NC investigations.

• (5%) Support Post Market Surveillance activities, Quality Management Reviews, and internal/external audits or inspections

What will you need to be successful:

• Education: Bachelor's degree in Engineering

• Experience: 0-2 years' of practical hands-on experience in quality engineering. Internships and co-op experience.

• Travel Requirements: <10%

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, 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

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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.