Quality Assurance Engineer 1

Quality Engineer

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

The Quality Engineer is responsible for supporting the Smith & Nephew Quality Management Systems. The Quality Engineer will ensure that the Regulations, Standards and Guidelines are compiled and that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act.

What will you be doing?

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Supports new product development and implementation via the project quality plans which may include needed inspection, test, and audit procedures
• Assist with identification of needed reliability testing, storage stability testing, biological testing, and sterilization adoptions
• Identification and procurement of needed gauges, equipment, etc.
• Work with Product Development team to perform design control activities for product revision and line extensions which may include risk assessments, test plan review, gaging and measurement studies, process verification and validation
• Participate in post market surveillance process and coordinates monthly PMS trend reviews as assigned
• Participate as a trainer in Quality Control and Manufacturing employee training programs
• Develop and work with area teams to implement continuous quality improvement programs which may include vendor verification for ship to stock, design of experiments to identify and control process variables, elimination of lot inspection and initiation of process audit activities, and installation of statistical and non-statistical process controls

What will you need to be successful?

• Bachelor's of Science in Mechanical, Biomedical, Packaging, or related Engineering discipline
• 0 to 2 years of experience in the medical device industry or another regulated environment
• Must be able to communicate effectively, both verbally and in writing with Global teams, and build productive relationships.
• Effective project and time management, able to work independently and within cross functional team environments.
• Requires proficiency using PC Applications including Microsoft Word, Minitab, PowerPoint, MS Project, Visio, and Excel.
• Interacts with peers and management in other functional departments, as well as frequent interaction with production associates and external suppliers of equipment and materials.

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.