Quality Engineer 1 (Memphis, TN)

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

The Quality Engineer I is responsible for supporting quality assurance and quality control processes to ensure products and processes meet specified standards and customer expectations. This person will evaluate products, manufacturing processes, assembly processes, and supports quality control activities through training, inspection procedure preparation, and technical support. They also troubleshoot issues, provide technical guidance, and may collaborate with other departments to support production and quality assurance processes. This role requires strong technical knowledge in GD&T, effective communication, and attention to detail.

What will you be doing?

Product and Process Inspection:

• Conduct inspections and tests on products, materials, and equipment to verify quality.

• Check production processes for adherence to standards and identify any deviations.

• Document and report any quality issues or defects found during inspections.

Data Collection and Analysis:

• Collect and analyze data related to product quality and process performance.

• Use statistical tools to track quality metrics and trends, such as defect rates or customer complaints.

• Identify patterns or areas for improvement based on data analysis.

Documentation and Reporting:

• Maintain records of inspection results, testing data, and quality reports.

• Help create and update quality documentation, such as standard operating procedures (SOPs) and quality control plans.

• Report quality issues to senior engineers or supervisors and help implement corrective actions.

Root Cause Analysis and Problem-Solving

• Assist in identifying the root causes of quality issues and work with other teams to find solutions.

• Participate in problem-solving efforts, such as failure mode and effects analysis (FMEA) or root cause analysis (RCA).

• Implement corrective and preventive actions (CAPA) to reduce the likelihood of recurring issues.

Support for Audits and Compliance

• Assist in internal and external audits to ensure compliance with quality standards, such as ISO 9001 and 13485, 21CFR, and/or industry-specific requirements.

• Ensure products and processes comply with regulatory requirements and company policies.

• Work with teams to address audit findings and implement improvements.

Collaboration and Communication

• Work closely with production, engineering, and other teams to communicate quality standards and expectations.

• Provide training or guidance to team members on quality procedures and best practices.

• Help foster a culture of continuous improvement by supporting quality initiatives and projects.

Learning and Development

• Stay updated on industry trends, quality standards, and best practices.

• Participate in training and development programs to improve technical skills, knowledge, and career growth.

• Supporting site CAPA process and owners to drive timely completion of CAPAs.

• Data analysis and metrics reporting

• Training, other project support, audit support, etc.

What will you need to be successful?

• Education:

  • B.S. of Engineering or related experience in a technical field preferred.

• Experience:

  • 0 - 2 years related experience in medical device, quality control, and/or manufacturing preferred.

  • Professional certification such as ASQ Certified Calibration Technician (CCT) or ISO/IEC certification preferred.

  • Previous internship/Co-op related experience preferred.

• Knowledge of statistics preferred                                                        

• Experience/knowledge of QSR and ISO preferred

• Experience in inspection procedures/methods preferred

• Strong computer, scientific, and organizational skills

• Excellent documentation and written/verbal communication skills

• Strong planning, organizational, critical thinking, and problem-solving skills

• Ability to work independently with so