Senior Operations Quality Engineer – Medical Devices

Medtronic plc; North Haven (CT); Hybrid; USD 98,000 - 148,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401(k) with match

Paid Time Off

Job summary

Medtronic in North Haven, CT seeks a Senior Operations Quality Engineer to lead quality initiatives across ASI stapling product families in a hands-on manufacturing environment. You will drive investigations, CAPA, and validation efforts with cross-functional teams to ensure compliance, reliability, and operational excellence.

The role requires onsite presence five days a week and offers generous benefits and a strong pay package reflecting senior responsibilities in a regulated medical device

Qualifications

• Bachelor's degree with 4+ years quality/manufacturing experience
• Experience with regulated manufacturing environments
• Knowledge of quality systems and applicable standards (QSR, ISO 13485)

Responsibilities

• Lead quality initiatives to improve product and process quality.
• Partner with manufacturing and engineering to establish, maintain, and enhance quality standards.
• Develop inspection, testing, validation, and monitoring strategies for products and processes.
• Execute root cause investigations and ensure effective CAPA implementation.

Skills

Quality engineering

Regulatory compliance

Root cause analysis

Cross-functional collaboration

Education

Bachelor's degree in engineering or quality field

Job description

Medtronic in North Haven, CT seeks a Senior Operations Quality Engineer to lead quality initiatives across ASI stapling product families in a hands-on manufacturing environment. You will drive investigations, CAPA, and validation efforts with cross-functional teams to ensure compliance, reliability, and operational excellence.

The role requires onsite presence five days a week and offers generous benefits and a strong pay package reflecting senior responsibilities in a regulated medical device