Quality Assurance Engineer (Austin, TX)

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

This position will implement, support, and sustain elements of Smith + Nephew's Quality System through procedure generation, training, auditing, and technical support. The Quality Assurance Engineer I determines methods, techniques, and evaluation criteria for medical devices, specifically High Frequency surgical equipment. He/she serves as a key resource for ISO, EN, MDD, MDR, and QSR requirements.

**This position does not offer visa transfer or sponsorship now or in the future**

This role requires a completed degree Winter 2024 or earlier.

What will you be doing?

• Provide quality leadership to new product development project (PDP) and/or sustaining project teams as the Quality Engineering representative on projects requiring FDA 510k, CE Mark, and international regulatory approval.

• Work with a team to develop verification and validation test methods and procedures to ensure that the appropriate tests are conducted to assure that embedded software, analog and digital electronic circuits, and support hardware used within instrument products meet the required specifications/standards and that the safety and reliability of products are established.

• Generate/approve/manage software and design verifications, design validations, usability / human factors, reliability testing, process validations, supplier qualifications, test methods, capability studies, and risk management documentation to support the product DHF. Interface with R&D and manufacturing engineers to identify and resolve defects and product quality issues.

• Support manufacturing operations and provide expertise in product requirements, risk management, test methods, and statistical analysis.

• Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD / MDR, and NMPA requirements. Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.

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

• Support continuous improvement activities (CCRs and/or PARs).

• Support Post Market Surveillance activities, Management Review, and audits/inspections.

What will you need to be successful?

• Education: B. S. in Electrical, Computer, or Biomedical Engineering or related discipline, M.S. in Engineering preferred. (Must currently have a completed degree Winter 2024 or earlier)

• Experience: 0-2 years in medical device or related industry

• ASQ CQE / CRE (preferred)

• Equipment proficiency preferred with Oscilloscopes, Function Generators, and Digital Multimeters

• Software proficiency preferred in the following:

  • Requirement management tool (such as Jama or Cockpit)

  • Defect tracking tool (such as Jira)

  • C / Python programming languages

• 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.