Senior Quality Engineer - Medical Devices, Onsite

Medtronic; Jacksonville (FL); On-site; USD 98,000 - 148,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Bonus/incentives

Job summary

Medtronic in Jacksonville, FL seeks a Senior Quality Engineer to lead quality initiatives across manufacturing operations, incoming inspection, and product release. You will collaborate with Manufacturing, Operations, Supplier Quality, and Engineering to drive process improvements and compliance with FDA QSR, ISO 13485, and GMP standards.

The role is onsite, requires five days per week on the factory floor, with up to 20% travel.

Qualifications

• Bachelor's degree in a related field with 4+ years in quality engineering or manufacturing quality
• ASQ CQE or comparable certification preferred
• Experience with FDA QSR, ISO 13485, ISO 14971, GMP, and other regulatory standards

Responsibilities

• Lead quality operations and ensure compliance with regulatory standards
• Analyze quality data to identify process improvements and risk reductions
• Lead projects for incoming inspection, material acceptance, and product release
• Partner with Manufacturing, Operations, and Engineering to maintain quality standards and inspection requirements
• Investigate nonconformances and implement corrective actions

Skills

FDA QSR knowledge

ISO 13485

GMP familiarity

Audit planning

Statistical analysis

Minitab

Excel

Power BI

CAPA

Root cause analysis

Education

Bachelor's degree

Master's degree

PhD

Tools

Minitab

Power BI

Microsoft Excel

Job description

Medtronic in Jacksonville, FL seeks a Senior Quality Engineer to lead quality initiatives across manufacturing operations, incoming inspection, and product release. You will collaborate with Manufacturing, Operations, Supplier Quality, and Engineering to drive process improvements and compliance with FDA QSR, ISO 13485, and GMP standards.

The role is onsite, requires five days per week on the factory floor, with up to 20% travel.