Senior Supplier Quality Engineer — Global Quality Leader

Atricure, Inc.; Northern (KY); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental benefits

401K with match

Parental Leave

On-site fitness center

Job summary

AtriCure, Inc. is seeking a Supplier Quality Engineer to develop and implement supplier-related quality systems, ensuring compliance with FDA and ISO requirements for new product development and manufacturing.

You will lead supplier audits, evaluate First Articles, and drive NCR/SCAR resolution while coordinating with Quality, Development, and Operations teams to improve supplier performance and product quality.

Qualifications

• Bachelor’s degree in a related field.
• 4+ years of experience in supplier quality or quality assurance.
• Experience with FDA and ISO 13485 audits.
• Willingness to travel up to 25%.
• Strong data analysis and problem-solving skills.

Responsibilities

• Develop and maintain supplier-related procedures compliant with FDA, MDD, CMDR, and ISO.
• Lead supplier audits, assessments, and QMS qualification activities.
• Manage NCRs/SCARs and supplier change requests.
• Collaborate with Quality, Product Development and other departments on strategy.
• Support NPD activities at suppliers and sustainment of existing components.
• Mentor junior SQEs and drive continuous improvement.

Skills

FDA regulations

ISO 13485

Audits

QMS qualification

Supplier audits

Control plans

Measurement systems

NCRs/SCARs

Cross-functional

Documentation

Education

Bachelor’s degree in a related field

Tools

MS Office

Minitab

Quality management software

Job description

AtriCure, Inc. is seeking a Supplier Quality Engineer to develop and implement supplier-related quality systems, ensuring compliance with FDA and ISO requirements for new product development and manufacturing.

You will lead supplier audits, evaluate First Articles, and drive NCR/SCAR resolution while coordinating with Quality, Development, and Operations teams to improve supplier performance and product quality.