Quality Assurance Coordinator

Job Description

Job Description

Position Summary

We are seeking an experienced Quality Assurance Coordinator to develop, implement, and maintain our quality management systems while ensuring compliance with ASME, ISO 9001, and ISO 13485 standards. This role combines both quality system leadership and hands-on inspection responsibilities within a metal fabrication environment.

Key Responsibilities

• Develop, implement, and maintain an ISO 9001-compliant Quality Management System (QMS)
• Support the company’s efforts to achieve ISO 9001 certification
• Ensure compliance with ASME Section VIII, Division 1 and applicable ISO standards
• Perform quality control inspections in accordance with documented procedures
• Conduct internal audits and ensure ongoing compliance with quality standards
• Lead corrective and preventive action (CAPA) processes, including tracking and follow-up
• Train employees on quality procedures, standards, and best practices
• Manage and coordinate customer audits and notified body inspections
• Monitor, track, and report key performance indicators (KPIs) related to quality
• Collaborate with production and engineering teams to drive continuous improvement initiatives
• Maintain accurate and complete quality documentation and records

Qualifications

• Minimum 5 years of experience developing and maintaining an ISO 9001-compliant quality system
• Experience in a metal fabrication environment is required
• Strong knowledge of ASME Code (Section VIII, Div. 1) is highly preferred
• Experience with ISO 13485 and medical device manufacturing/sterilization processes is a plus
• Proven experience conducting audits, inspections, and CAPA processes
• Strong attention to detail, organization, and problem-solving skills
• Excellent communication and training abilities

Additional Requirements

• Ability to work both independently and collaboratively across departments
• Willingness to travel domestically and internationally as needed