Quality Engineer II, Medical Devices - Lead Investigations

Smith Nephew; Maple Plain (MN); Híbrido; USD 74.000 - 112.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401k Matching Program

Tuition Reimbursement

Medical Insurance

Dental Insurance

Vision Insurance

Parental Leave

Fertility and Adoption Assistance

Hybrid Work Model

Descripción de la vacante

Smith+ Nephew is hiring a Quality Engineer II in Maple Plain, Minnesota. You will own and drive manufacturing quality objectives, lead investigations into nonconformances and supplier issues, and provide hands-on quality support for sterile packaging and sterilization processes.

You will work cross-functionally across Manufacturing Engineering, Process Development, R&D, Purchasing, and Quality to embed quality in new and expanding lines.

Formación

• Bachelor's degree with at least 2 years of related work experience; engineering degree preferred.
• Experience leading investigations or corrective actions in medical devices or regulated manufacturing environments.
• Strong written and verbal communication; ability to work independently; ability 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, nonconformances, material discrepancies, and customer complaints; develop corrective/preventive actions.
• Provide hands-on quality support for manufacturing processes, including sterile packaging and sterilization activities.
• Lead cross-functional quality and continuous improvement projects using problem solving and lean quality principles.
• Partner with Manufacturing Engineering, Process Development, R&D, Purchasing, and Quality to integrate quality into new manufacturing lines.
• Monitor supplier and incoming material quality; support supplier corrective actions.
• Apply inspection methods, drawings, measurements, sampling plans, and nonconforming material controls.
• Provide technical guidance and training to junior team members and inspection personnel.
• Maintain quality records and support regulatory compliance.

Conocimientos

Quality engineering

Regulatory compliance

Root cause analysis

Process validation

Cross-functional collaboration

Educación

Bachelors in engineering

Herramientas

Inspection methods

Engineering drawings

Measurement tools

Sampling plans

Quality documentation

Process controls

Descripción del empleo

Smith+ Nephew is hiring a Quality Engineer II in Maple Plain, Minnesota. You will own and drive manufacturing quality objectives, lead investigations into nonconformances and supplier issues, and provide hands-on quality support for sterile packaging and sterilization processes.

You will work cross-functionally across Manufacturing Engineering, Process Development, R&D, Purchasing, and Quality to embed quality in new and expanding lines.