Senior Quality Engineer - Medical Devices (Onsite)

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

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) with employer match

Paid time off

Job summary

Medtronic CST in Boxborough, MA seeks a Senior Quality Engineer to lead quality activities across manufacturing operations, drive process improvements, and support regulatory compliance throughout the product lifecycle.

You will collaborate with cross-functional teams, investigate quality issues, and develop robust quality documentation and validation protocols in a fast-paced medical device environment onsite.

Qualifications

• Bachelor's degree or higher in a relevant field with 4+ years of experience in quality engineering or manufacturing.
• Experience applying quality tools for root cause analysis and process improvement.
• Experience working in a regulated environment with quality systems.
• Knowledge of process validation, risk management, and quality engineering methodologies.

Responsibilities

• Lead quality engineering activities supporting manufacturing processes and product quality performance.
• Collaborate with Manufacturing, Operations, and R&D to implement process improvements and quality controls.
• Analyze quality data, identify trends, and drive corrective and preventive actions for nonconformances.
• Support root cause investigations and resolution of quality issues across product, process, and supplier quality.
• Develop, review, and approve quality documentation, validation protocols, and engineering changes.
• Ensure compliance with Quality Management System requirements and regulatory standards.
• Participate in risk assessments and drive continuous improvement initiatives.

Skills

Quality engineering

Root cause analysis

Regulatory compliance

Quality data analysis

Process validation

Risk management

Education

Bachelor's degree

Advanced degree

Job description

Medtronic CST in Boxborough, MA seeks a Senior Quality Engineer to lead quality activities across manufacturing operations, drive process improvements, and support regulatory compliance throughout the product lifecycle.

You will collaborate with cross-functional teams, investigate quality issues, and develop robust quality documentation and validation protocols in a fast-paced medical device environment onsite.