Senior Quality Engineer — Process Validation & Compliance

Medtronic; North Haven (CT); On-site; USD 98,000 - 148,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) with Company Match

Paid Time Off

Paid Holidays

Employee Stock Purchase Plan

Tuition Assistance

Job summary

Medtronic in North Haven, CT seeks a Senior Quality Engineer to lead process validation and quality-system execution in a regulated medical-device environment. You will partner with engineering and manufacturing to ensure compliant, capable processes, drive CAPA, and support continuous improvement with data-driven decision making.

The role requires a BS (or higher) in engineering/science with several years in process validation and quality, and offers an onsite schedule five days a week with

Qualifications

• BS/BE in Engineering, Science or technical field with 4+ years in eng/quality or MS with 2+ years, or PhD.
• 2+ years of experience executing process validation throughout full lifecycle.

Responsibilities

• Lead process validation activities across the full validation lifecycle (planning, protocol development, execution, analysis, reporting, monitoring).
• Partner with manufacturing and engineering to develop, implement, and maintain quality standards and controls.
• Drive CAPA and NCMR activities to resolve quality issues and prevent recurrence.
• Analyze quality and process data using statistical methods to support risk-based decisions and continuous improvement.
• Develop and implement inspection, testing, and evaluation methods to verify product quality and process capability.
• Support qualification and validation of manufacturing equipment, processes, and test methods.
• Ensure quality documentation and compliance with regulatory and quality system requirements.
• Mentor colleagues and provide technical leadership on complex quality projects.

Skills

Process validation

Quality engineering

Statistical analysis

Regulatory compliance

Root cause analysis

Education

Bachelor's degree in Engineering/Science

Master's degree in Engineering/Science

PhD

Tools

Minitab

Job description

Medtronic in North Haven, CT seeks a Senior Quality Engineer to lead process validation and quality-system execution in a regulated medical-device environment. You will partner with engineering and manufacturing to ensure compliant, capable processes, drive CAPA, and support continuous improvement with data-driven decision making.

The role requires a BS (or higher) in engineering/science with several years in process validation and quality, and offers an onsite schedule five days a week with