Supplier Quality Engineer 2 (Austin, TX)

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

The Supplier Quality Engineer supports the supplier quality global strategy according to the annual goals and objectives established in workday during the annual goal setting. This role demands a blend of technical skills, compliance knowledge, and cross-functional collaboration, emphasizing maintaining high supplier quality standards and meeting regulatory requirements for medical devices.

What will you be doing?

Supplier Product Quality Management:

• Support supplier non-conformant products investigations, including managing issues in tools like Smart Solve and SAP.

Compliance and Documentation:

• Ensure suppliers meet regulatory requirements, including maintaining up-to-date ISO certifications.

Problem Resolution:

• Collaborate closely with engineers, sites, and suppliers to resolve quality issues.

• Support corrective and preventive actions (CAPAs) to address supplier-related problems.

Audit and External Support:

• Support external audits if needed, such as MDSAP and FDA inspections, to ensure supplier compliance.

Project and Time Management:

• Plan and manage project schedules, providing progress updates as needed.

Collaboration:

• Work independently and within cross-functional teams to execute engineering and quality activities.

Support Business Objectives:

• Participate in and contribute to other business needs or projects as required.

What will you need to be successful?

• Education:

  • Bachelor's degree in Mechanical, Biomedical, or a related Engineering discipline required.

• Certifications:

  • ISO 13485 Auditor Certification or familiarity with ISO 19011 auditing principles preferred

  • Six Sigma Green Belt or other relevant quality certifications preferred

• Experience:

  • Industry Expertise: At least 2-5 years of experience in supplier quality management, quality assurance, or engineering within the medical device or a related regulated industry.

  • Problem-Solving Tools: Proficiency in methodologies such as Lean A3, Six Sigma, or 8D for addressing quality challenges.

  • Regulatory Knowledge: Familiarity with ISO 13485, FDA regulations, and other relevant quality and regulatory standards.

  • Collaboration: Proven experience working in cross-functional teams and with external suppliers, ensuring compliance and addressing quality issues.

• Proficiency in using software like SAP, Smart Solve, Power BI, Microsoft Office Suite, and quality tools (e.g., Minitab).

• Strong communication and collaboration skills, both within the company and with external suppliers.

• Knowledge of ISO 13485 and ISO 19011 (preferable), as well as problem-solving methodologies like Lean A3, Six Sigma, and 8D.

• Travel Requirements: 10% (Availability to travel occasionally to supplier locations, audit sites, and other facilities).

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

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.