Quality Assurance Engineer (North Austin, TX)

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

At Smith + Nephew’s site located in North Austin, we process orthopedic implants and instruments essential to improving patients’ lives. The Quality Assurance Engineer 2 is responsible to develop and maintain processes that support the operation of Quality Management’s day-to-day efforts to ensure product quality and patient safety.

What will you be doing?

Process Development, Measurement, and Improvement

• Develop processes and programs to support the Quality System, such as validation protocols, inspection documents, procedures, policies, and other projects.
• Implement process improvements in conjunction with business stakeholders.
• Develop inspection techniques and procedures.
• Support training in Quality Control and Manufacturing.
• Assist in development process monitoring and development for manufacturing transfer / new product development projects.

Investigations

• Work with suppliers, quality control, engineers, and manufacturing personnel to resolve quality problems. Assist in development of capability studies and application of statistical quality control.
• Investigates non-conformances (NCs) in NC and CAPA systems.
• Implements corrections, corrective actions, and preventive actions.
• Facilitates review of NCs to prioritize resources and escalate potential issues.
• Plans disposition of product with a cross functional team.
• Support product complaint investigations and product risk assessment / health hazard assessments as directed.

Audit Support

• Participate in external regulatory agency audits, including representing assigned Quality Management System elements with auditors.
• Actively prepare for audits to ensure audit readiness.
• Other activities as agreed with management and senior-level QEs.

What will you need to be successful?

• Education:
  • Bachelor’s degree in engineering or Sciences;
  • American Society of Quality certifications preferred, such as Certified Quality Engineer (CQE).
  • Lean Six Sigma is beneficial.
• Experience:

• A minimum of 3 years’ experience in a Quality/Design/Manufacturing Engineer or focused Quality Management Systems role in a regulated industry (Medical Device, Pharma, Aerospace, etc.) is required. 
• Preferred 2 years’ experience with sterile devices, clean room activities and project management.
• Experience with MS Office 360 (Outlook, Word, Excel, PowerPoint) is required.
• Minimum of 2 years’ experience with eQMS and PLM systems is preferred.
• Strong working knowledge in FDA and/or ISO regulations is required.
• Ability to read and comprehend product drawings. Experience with Geometric Dimensioning and Tolerancing preferred.
• Solid work ethic with an ability to work independently and be a self-starter. 
• Strong communication skills, detail oriented, collaborative, strong interpersonal skills, and good organizational skills.
• Creativity with implementing solutions that solve problems using root cause analysis techniques.
• Ability to lift up to 30 lbs, sit for extended periods of time at a desk, or stand for extended periods.
• Ability to comply with all Safety policies as applicable, including mandated personal protection equipment (PPE).

• Travel Requirements: up to 10%

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients 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 Assistanc