Quality Engineer II: Root Cause & Process Excellence

Safeguard Medical Ltd; Huntersville (NC); Hybrid; USD 80,000 - 110,000; Full time

Job summary

Safeguard Medical Ltd. is seeking a Quality Engineer to join a cross-functional team focused on quality management for operational support. You will apply root cause analysis, DO/DAO change management, SPC, and CAPA processes to drive product and process improvements.

This role interfaces with manufacturing, suppliers, and quality teams to ensure regulatory compliance and robust quality systems. The ideal candidate has 3–6 years in medical devices with experience in risk management, validation

Qualifications

• Bachelor’s degree in a STEM discipline or equivalent experience.
• 3–6 years’ experience in medical device or pharmaceutical field preferred.
• Experience with risk identification, mitigation and risk management.
• Experience with manufacturing processes and related documentation preferred.
• Experience with sterilization and packaging validation activities preferred.

Responsibilities

• Execute Quality Engineering activities for Operational support, including risk management, design verification/validation, and process validation.
• Perform root cause analysis and implement corrective and preventive actions (CAPA/SCAR); support NC and CAPA systems.
• Use statistical tools to analyze data, determine sample sizes, apply SPC, and interpret results.
• Support clean room monitoring and environmental controls.
• Collaborate with quality control, manufacturing and warehouse to implement processes and improvements.
• Assist supplier management including selection, qualification and performance improvement.
• Develop and validate test methods; apply metrology techniques and Gage R&R studies.

Skills

Root cause analysis

Statistical methods

Quality systems

Cross-functional teamwork

Problem solving

Education

Bachelor’s degree in STEM

Tools

Minitab

Gage R&R

3D modeling

Job description

Safeguard Medical Ltd. is seeking a Quality Engineer to join a cross-functional team focused on quality management for operational support. You will apply root cause analysis, DO/DAO change management, SPC, and CAPA processes to drive product and process improvements.

This role interfaces with manufacturing, suppliers, and quality teams to ensure regulatory compliance and robust quality systems. The ideal candidate has 3–6 years in medical devices with experience in risk management, validation