Senior Quality Engineer — Drive Process & Product Quality

Medtronic plc; Boston (MA); On-site; USD 98,000 - 148,000; Full time

Benefits offered by this job

Health insurance

Dental and vision insurance

401(k) plan

Employee Stock Purchase Plan

Job summary

Medtronic in Boxborough, MA is seeking a Senior Quality Engineer to support manufacturing operations, drive process improvements, and ensure regulatory compliance throughout the product lifecycle. The role collaborates across Quality, Manufacturing, Operations, R&D, and Regulatory Affairs and is onsite with no travel.

You will lead quality initiatives, analyze data, investigate issues, and develop documentation and validation protocols while ensuring QMS compliance and risk management practices

Qualifications

• Bachelor’s degree and 4+ years of quality engineering, manufacturing, or regulated industry experience, or an advanced degree with 2+ years of quality engineering, manufacturing, or regulated industry experience.
• Experience applying quality tools for root cause analysis, corrective actions, and process improvement.
• Experience supporting quality systems within a regulated environment.
• Experience analyzing quality data and developing effective quality solutions.
• Working knowledge of process validation, risk management, or quality engineering methodologies.

Responsibilities

• Lead quality engineering activities supporting manufacturing processes and product quality performance.
• Partner with Manufacturing, Operations, and Research and Development teams to implement process improvements and quality controls.
• Analyze quality data, identify trends, and drive corrective and preventive actions to address nonconformances.
• Support root cause investigations and resolution of product, process, and supplier quality issues.
• Develop, review, and approve quality documentation, procedures, validation protocols, and engineering changes.
• Ensure compliance with applicable Quality Management System requirements and regulatory standards.
• Participate in risk management activities and support product and process risk assessments.
• Drive continuous improvement initiatives that enhance product quality, process capability, and operational performance.

Skills

Quality engineering

Root cause analysis

Process improvement

Quality systems

Quality data analysis

Process validation

Risk management

Quality engineering methodologies

Education

Bachelor's degree

Advanced degree

Job description

Medtronic in Boxborough, MA is seeking a Senior Quality Engineer to support manufacturing operations, drive process improvements, and ensure regulatory compliance throughout the product lifecycle. The role collaborates across Quality, Manufacturing, Operations, R&D, and Regulatory Affairs and is onsite with no travel.

You will lead quality initiatives, analyze data, investigate issues, and develop documentation and validation protocols while ensuring QMS compliance and risk management practices