Quality Assurance Engineer (North Austin, TX)

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

Do you have the skills to fill this role Read the complete details below, and make your application today.

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.

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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