Quality Engineer II – Medical Devices (Hybrid)

Smith & Nephew; Maple Plain (MN); Hybrid; USD 74,000 - 112,000; Full time

Benefits offered by this job

Health, dental, vision insurance

401(k) matching

Tuition reimbursement

Flexible time off

Job summary

Smith+Nephew in Maple Plain, MN is seeking a Quality Engineer II to own and drive manufacturing quality objectives, including product performance, process control, and compliance. You will lead investigations into quality events, develop CAPAs, and provide hands-on support for sterile packaging and sterilization.

The role partners with multiple functions to ensure quality is embedded in new and expanding manufacturing lines, with emphasis on problem solving and lean quality principles.

Qualifications

• Experience leading investigations or corrective actions in medical devices or regulated manufacturing.
• Knowledge of inspection methods, engineering drawings, measurement tools, sampling plans, quality documentation, and manufacturing process controls.
• Ability to lift up to 20 pounds and work with limited supervision.

Responsibilities

• 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, developing effective 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, applying 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.

Skills

Quality engineering

Investigations leadership

Communication skills

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Engineering

Job description

Smith+Nephew in Maple Plain, MN is seeking a Quality Engineer II to own and drive manufacturing quality objectives, including product performance, process control, and compliance. You will lead investigations into quality events, develop CAPAs, and provide hands-on support for sterile packaging and sterilization.

The role partners with multiple functions to ensure quality is embedded in new and expanding manufacturing lines, with emphasis on problem solving and lean quality principles.