Quality Engineer II - Medical Devices (Hybrid, Tuition Reimb)

Smith & Nephew; Town of Maple Plain (WI); Híbrido; USD 74.000 - 112.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401k Matching Program

Discounted Stock Purchase Plan

Tuition Reimbursement

Medical Insurance

Parental Leave

Descripción de la vacante

Smith+ Nephew is seeking a Quality Engineer II in Maple Plain, MN, to own manufacturing quality objectives and lead investigations into product and process issues. You will support sterile packaging and sterilization, apply lean quality principles, and collaborate across engineering, manufacturing, purchasing, and quality teams.

The role emphasizes hands-on quality support, cross-functional projects, and the ability to guide others while maintaining clear quality records in a regulated medical

Formación

• Bachelor's degree with at least 2 years of related experience; a four-year engineering degree is preferred.
• Experience leading investigations or corrective action projects in medical devices or regulated manufacturing.
• Working knowledge of inspection methods, drawings, measurement tools, sampling plans, quality documentation, and process controls.
• Experience across multiple manufacturing quality functions (receiving inspection, incoming quality control, supplier quality, sterile packaging, sterilization, process validation).
• Strong written and verbal communication; able to work independently with limited supervision.
• Must be able to lift up to 20 pounds.

Responsabilidades

• Own and execute manufacturing quality objectives focused on product performance, process control, compliance, and scalability.
• Lead investigations into quality events and develop corrective actions.
• Provide hands-on quality support for manufacturing processes including sterile packaging and sterilization.
• Lead cross-functional quality and continuous improvement projects.
• Partner with Manufacturing Engineering, Process Development, R&D, Purchasing and Quality to integrate quality into new lines.
• Monitor supplier and incoming material quality performance and support supplier corrective actions.
• Provide training and maintain quality records with regulatory compliance.

Conocimientos

Investigation

Lean quality

Quality records

Sterile packaging

Educación

Bachelor's degree in engineering

Four year engineering degree preferred

Herramientas

Inspection methods

Engineering drawings

Measurement tools

Process validation

Descripción del empleo

Smith+ Nephew is seeking a Quality Engineer II in Maple Plain, MN, to own manufacturing quality objectives and lead investigations into product and process issues. You will support sterile packaging and sterilization, apply lean quality principles, and collaborate across engineering, manufacturing, purchasing, and quality teams.

The role emphasizes hands-on quality support, cross-functional projects, and the ability to guide others while maintaining clear quality records in a regulated medical