Quality Engineer II: Drive Quality & Process Improvement

Safeguard Medical; Huntersville (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

Safeguard Medical in Huntersville, NC seeks a Quality Engineer to join a cross-functional team. You will oversee quality management for operational support, apply root cause analysis, and drive improvements across the quality system while collaborating with operators, inspectors, and management.

Candidates bring a STEM degree, 3–6 years in medical device or pharma, and experience with risk, SPC, and Minitab.

Qualifications

• Bachelor's degree in STEM or equivalent experience.
• 3-6 years in the medical device or pharmaceutical field preferred.
• Technical knowledge of the medical device industry.
• Must have experience in risk identification, mitigation, and risk management.

Responsibilities

• Executes Quality Engineering activities related to Operational support, including risk management, design verification and validation, and process validation.
• Performs root cause analysis of identified issues and implements corrective and preventive actions (CAPA).
• Uses statistical tools (SPC, data analysis, sampling) to draw conclusions and inform decisions.
• Supports clean room monitoring and environmental controls.
• Ensures compliance with Quality Management System practices and supports supplier-related activities.

Skills

Root cause analysis

Statistical analysis

Cross-functional collaboration

Project management

Quality system knowledge

Education

Bachelor's degree in STEM

Tools

Minitab

Job description

Safeguard Medical in Huntersville, NC seeks a Quality Engineer to join a cross-functional team. You will oversee quality management for operational support, apply root cause analysis, and drive improvements across the quality system while collaborating with operators, inspectors, and management.

Candidates bring a STEM degree, 3–6 years in medical device or pharma, and experience with risk, SPC, and Minitab.