Senior Operations Quality Engineer - Medical Devices

COV Covidien LP; North Haven (CT); On-site; USD 121,000 - 181,000; Full time

Job summary

Medtronic in North Haven, CT, seeks a Principal Operations Quality Engineer to lead quality strategy across Stapling product families in a manufacturing setting. You will guide quality systems, interfaces with engineering and manufacturing, and ensure compliance with FDA ISO13485 and other standards.

The role requires a strong technical background, autonomy to drive improvements, and a track record of complex investigations and high-stakes decision making within a regulated environment.

Qualifications

• Bachelor's degree with 7+ years in quality/manufacturing or Master's with 5+ years.
• Experience in a regulated manufacturing environment.

Responsibilities

• Lead development and maintenance of quality standards and procedures for manufacturing operations.
• Partner with Engineering and Manufacturing to integrate quality requirements into products and controls.
• Develop inspection and testing methods to verify product performance and process capability.
• Design and oversee inspection/testing systems for quality assessment.
• Conduct root cause analyses and risk assessments to drive CAPA actions.
• Ensure documentation complies with internal procedures and regulatory standards.
• Lead quality improvement initiatives and guide cross-functional teams.
• Mentor quality professionals and participate in strategic projects.

Skills

Quality engineering

Root cause analysis

Statistical analysis

Regulatory compliance

Mentoring

Education

Bachelor's degree in engineering or related field

Master's degree in engineering or related field

PhD in a relevant field

Tools

CAPA systems

Change control systems

Job description

Medtronic in North Haven, CT, seeks a Principal Operations Quality Engineer to lead quality strategy across Stapling product families in a manufacturing setting. You will guide quality systems, interfaces with engineering and manufacturing, and ensure compliance with FDA ISO13485 and other standards.

The role requires a strong technical background, autonomy to drive improvements, and a track record of complex investigations and high-stakes decision making within a regulated environment.