Senior Supplier Quality Engineer – Med Device Compliance

AtriCure, Inc.; Mason (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical & Dental

401K match

Parental leave

Volunteer time off

Pet Insurance

On-site fitness center

Cafeteria

Job summary

AtriCure, Inc. is hiring a Supplier Quality Engineer to develop and implement supplier-related quality system requirements. You will work across Quality Management, Product Development, and other departments to ensure regulatory compliance and continuous improvement.

Responsibilities include supplier audits, NCR/SCAR management, and qualification activities for components and sub-assemblies, with travel as needed to support the supplier network.

Qualifications

• Details-oriented with strong problem solving/trouble shooting experience.
• Read technical specifications, blueprints, and drawings.

Responsibilities

• Develop and maintain supplier-related procedures in compliance with FDA, MDD, CMDR, ISO requirements.
• Lead supplier audits and assessments; manage NCRs/SCARs and supplier changes.
• Collaborate with Quality Management, Product Development and other departments.
• Support both New Product Development activities at suppliers and sustaining activities for existing components.

Skills

Attention to detail

Problem solving

Communication skills

Blueprint reading

Education

Bachelor’s degree in engineering

ASQ Certified Quality Engineer

ASQ Certified Lead Auditor

Tools

Audits

Job description

AtriCure, Inc. is hiring a Supplier Quality Engineer to develop and implement supplier-related quality system requirements. You will work across Quality Management, Product Development, and other departments to ensure regulatory compliance and continuous improvement.

Responsibilities include supplier audits, NCR/SCAR management, and qualification activities for components and sub-assemblies, with travel as needed to support the supplier network.