Quality Engineer II - Medical Devices | Hybrid Role

Regulatory Jobs; Minnesota; In loco; USD 74.000 - 112.000; Tempo pieno

Vantaggi offerti da questo lavoro

401k Matching Program

Discounted Stock Purchase Plan

Tuition Reimbursement

Work-Life Balance: Flexible Time Off

Descrizione del lavoro

Smith+Naphew's Integrity Orthopaedics unit in Maple Plain, Minnesota, is hiring a Quality Engineer II to own manufacturing quality objectives, lead investigations, and partner with engineering, manufacturing, purchasing, and quality teams to ensure product performance, process control and regulatory compliance across the site.

The role requires a bachelor’s degree with at least 2 years of related experience, strong communication skills, and hands-on quality support for sterile packaging and

Competenze

• Bachelor's degree with at least 2 years of related work experience; 4-year engineering degree preferred.

Mansioni

• 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, developing 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.
• 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.

Conoscenze

Quality assurance

Investigations

Process improvement

Cross-functional collaboration

Documentation

Training

Communication

Regulatory knowledge

Problem solving

Formazione

Bachelor's degree in Engineering

Strumenti

Sterile packaging equipment

Sterilization equipment

Measurement tools

Inspection equipment

Descrizione del lavoro

Smith+Naphew's Integrity Orthopaedics unit in Maple Plain, Minnesota, is hiring a Quality Engineer II to own manufacturing quality objectives, lead investigations, and partner with engineering, manufacturing, purchasing, and quality teams to ensure product performance, process control and regulatory compliance across the site.

The role requires a bachelor’s degree with at least 2 years of related experience, strong communication skills, and hands-on quality support for sterile packaging and