Manufacturing Quality Engineer II — Ops Excellence

Regulatory Jobs; North Haven (CT); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

Tuition reimbursement

401(k) with employer match

Paid time off

Job summary

Medtronic in North Haven, CT is seeking an Operations Quality Engineer II to lead quality initiatives in manufacturing, drive process improvements, and ensure compliance across production operations.

You will partner with engineering, manufacturing and quality teams to implement inspection, validation, CAPA, and data analysis strategies, aiming for product reliability and operational excellence. Onsite role, five days a week, with limited travel.

Qualifications

• Bachelor's degree with 2+ years of quality, manufacturing, or engineering experience.
• Experience with CAPA, quality systems, and regulatory compliance.
• Experience with process and product data analysis using statistical tools.

Responsibilities

• Support quality engineering initiatives to improve product quality and manufacturing performance.
• Partner with manufacturing and engineering to establish and enhance quality standards.
• Develop and implement inspection, testing, validation, and monitoring strategies.
• Analyze quality data to identify trends, investigate issues, and drive corrective actions.
• Lead root cause investigations and verify effectiveness of CAPA.
• Support audit readiness and compliant documentation.

Skills

Root cause investigations

CAPA implementation

Statistical analysis

Lean Six Sigma

Cross-functional collaboration

Education

Bachelor's degree in quality/manufacturing/engineering

Master's degree (optional)

Tools

Quality Systems (QSR/ISO 13485)

CAPA processes

Job description

Medtronic in North Haven, CT is seeking an Operations Quality Engineer II to lead quality initiatives in manufacturing, drive process improvements, and ensure compliance across production operations.

You will partner with engineering, manufacturing and quality teams to implement inspection, validation, CAPA, and data analysis strategies, aiming for product reliability and operational excellence. Onsite role, five days a week, with limited travel.