Quality Systems Engineer

Job Description

Job Description

Position Summary

The Quality Systems Engineer is the primary owner and administrator of the XLR8 EMS Quality Management System (QMS). This role is responsible for maintaining, monitoring, and continuously improving the company's quality system to ensure compliance with ISO 13485, AS9100, ISO 9001, ITAR, customer requirements, and applicable regulatory standards. The position is focused exclusively on quality system management, compliance, audits, document control, CAPA administration, training compliance, and certification maintenance, and does not have responsibility for manufacturing process quality, supplier quality, inspection activities, or product quality engineering.

Key Responsibilities

• Maintain compliance with ISO 13485, AS9100, ISO 9001, ITAR, and customer-specific requirements.
• Develop, revise, review, and control quality system procedures, policies, forms, and records.
• Manage document control processes, revision control, approvals, distribution, and record retention.
• Develop and execute the internal audit program and conduct system and compliance audits.
• Coordinate registrar, customer, and regulatory audits and ensure audit readiness.
• Administer the Corrective and Preventive Action (CAPA) system, including tracking, closure, and effectiveness verification.
• Support Management Review activities and prepare quality system performance metrics and reports.
• Maintain employee training matrices, competency records, and quality system training compliance.
• Monitor and implement changes related to quality standards, regulatory requirements, and customer requirements.
• Administer and maintain electronic quality management systems (eQMS) and related quality databases.
• Drive continual improvement of quality system processes and overall compliance effectiveness.

Required Qualifications

• Bachelor's degree in Engineering, Quality, Regulatory Affairs, Industrial Technology, or related field.
• 3–7 years of experience in Quality Systems, Quality Assurance, or Compliance within a regulated manufacturing environment.
• Working knowledge of ISO 13485, AS9100, ISO 9001, and ITAR requirements.
• Experience planning, conducting, and managing internal and external audits.
• Strong understanding of document control, CAPA systems, training management, and quality records management.
• Excellent organizational, communication, and project management skills.

Preferred Qualifications

• ASQ Certified Quality Auditor (CQA) or similar certification.
• AS9100 and/or ISO 13485 Lead Auditor certification.
• Experience in Electronics Manufacturing Services (EMS).
• Experience supporting Medical Device, Aerospace, and Defense industries.
• Experience with eQMS platforms and compliance management systems.

Benefits

• 401(k)
• 401 (k) matching
• Dental insurance
• Health insurance
  
• Vision insurance
• Paid time off