Quality Assurance Engineer 1

Smith & Nephew•Memphis, TN

9d•Hybrid

About The Position

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. As a Quality Assurance Engineer 1, you will play a key role in ensuring our products meet the highest quality and regulatory standards from design through to manufacture. Based in Memphis, Tennessee, this is an exciting opportunity to build your career within a global medical technology company where your work directly impacts patients’ lives.

Requirements

Bachelor of Science degree in Engineering, preferably Mechanical, Manufacturing or Biomedical Engineering
0 to 2 years of experience in the medical device industry or another regulated environment
Knowledge of Quality System Regulations and ISO requirements
Strong written and verbal communication skills with the ability to collaborate across global and cross functional teams
Proficiency in Microsoft Office applications

Nice To Haves

Minitab experience considered an advantage

Responsibilities

Supporting design control activities by creating and maintaining Design History File documentation
Coordinating and contributing to design reviews to ensure quality considerations are embedded throughout new product development
Developing and implementing incoming, in process and final inspection procedures to ensure products meet design specifications
Supporting risk management activities and contributing to the creation of risk management files
Partnering with cross functional teams including Manufacturing Engineering, Regulatory Affairs and suppliers to resolve quality issues
Assisting with process validations, capability studies and statistical quality control activities
Supporting internal and external audits and contributing to regulatory submissions including UL, IEC and FDA
Participating in training activities for Quality Control and Manufacturing teams