Quality Engineer 2

Smith+Nephew•Maple Plain, MN

2d•$74,250 - $111,500•Hybrid

About The Position

Smith+Nephew is hiring a Quality Engineer II to support Integrity Orthopaedics, now part of Smith+Nephew, in Maple Plain, Minnesota. The role independently owns and executes manufacturing quality objectives related to product performance, process control, compliance, and scalability. It provides hands-on quality support for manufacturing, including sterile packaging and sterilization, and partners with engineering, manufacturing, purchasing, research and development, and quality teams to integrate quality requirements into new and expanding manufacturing lines. The Quality Engineer leads investigations and corrective and preventive actions, supports supplier and incoming material quality, and contributes to cross-functional quality and continuous improvement projects. The position also provides technical guidance and training support while maintaining accurate quality records and supporting applicable regulatory compliance. A bachelor's degree and at least two years of related work experience are required, or an equivalent combination of education and experience. A four-year engineering degree is preferred. Applicants must be authorized to work in the United States without current or future employer sponsorship. The position requires the ability to lift up to 20 pounds.

Requirements

A bachelor's degree and at least 2 years of related work experience, or an equivalent combination of education and experience.
Experience independently leading investigations, improvement activities, or corrective action projects within medical devices or another regulated manufacturing environment.
Working knowledge of inspection methods, engineering drawings, measurement tools, sampling plans, quality documentation, and manufacturing process controls.
Strong written and verbal communication skills.
Ability to work independently with limited supervision and provide technical guidance to others.
Ability to lift up to 20 pounds.
Must be currently authorized to work in the United States and must not require Smith+Nephew sponsorship now or in the future to maintain that authorization.

Nice To Haves

A four-year engineering degree is preferred.
Experience across multiple manufacturing quality functions is preferred, particularly receiving inspection, incoming quality control, supplier quality, sterile packaging, sterilization, and process validation.

Responsibilities

Independently own and execute manufacturing quality objectives focused on product performance, process control, compliance, and scalability.
Lead investigations into manufacturing and product quality events, including nonconformances, process issues, material discrepancies, and customer complaints, and develop corrective and preventive actions.
Provide hands-on quality support for manufacturing processes, including sterile packaging and sterilization activities.
Lead defined cross-functional quality and continuous improvement projects, using practical problem solving and lean quality principles.
Partner with Manufacturing Engineering, Process Development, R&D, Purchasing, and Quality to integrate quality requirements into new and expanding manufacturing lines.
Monitor supplier and incoming material quality performance and support supplier corrective actions.
Apply inspection methods, engineering drawings and specifications, measurement tools, sampling plans, and nonconforming material controls.
Provide technical guidance and training support to less experienced team members and inspection personnel.
Maintain clear, accurate, and timely quality records while supporting compliance with applicable regulatory requirements.