Senior Supplier Quality Engineer - Med Device

AtriCure, Inc.; United States; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical & Dental from day 1

401K + match

Parental Leave

Job summary

AtriCure, Inc. is seeking a Supplier Quality Engineer to develop and implement supplier-related quality system requirements in support of new product development, manufacturing, and QMS activities with a focus on continuous improvement.

Responsibilities include maintaining supplier-related procedures in compliance with FDA regulations and ISO standards, directing supplier audits, and managing NCRs/SCARs. This role collaborates across Quality Management, Product Development, and suppliers to

Qualifications

• Bachelor's degree required or demonstrated equivalent combination of education, training and experience.
• 4+ years of experience in supplier quality engineering or related role.
• FDA and ISO 13485 knowledge and audit experience.

Responsibilities

• Develop and maintain supplier-related procedures and requirements in compliance to FDA regulations, MDD, CMDR, and ISO requirements.
• Direct and support supplier-related activities, including: QMS qualification and monitoring, supplier audits and assessments, and element qualification (First Articles, measurement systems, equipment and process qualifications, Control Plans).
• Manage NCRs and SCARs, supplier change requests and improvement.
• Collaborate with Quality Management, Product Development, and other departments to execute company strategies.
• Support New Product Development activities at suppliers and sustaining activities for existing components.

Skills

FDA regulations

ISO 13485

Supplier audits

QMS qualification

Measurement systems

Root cause analysis

Documentation

Education

Bachelor's degree or equivalent

Job description

AtriCure, Inc. is seeking a Supplier Quality Engineer to develop and implement supplier-related quality system requirements in support of new product development, manufacturing, and QMS activities with a focus on continuous improvement.

Responsibilities include maintaining supplier-related procedures in compliance with FDA regulations and ISO standards, directing supplier audits, and managing NCRs/SCARs. This role collaborates across Quality Management, Product Development, and suppliers to