The Quality Specialist supports the organization’s Quality Management System (QMS) and ensures compliance with ISO 9001 standards. This role is approximately 60% office based work focused on quality systems, documentation, and continuous improvement, and 40% time spent on the manufacturing floor conducting audits, inspections, and supporting production teams.

The Quality Specialist partners with cross-functional teams to maintain quality standards, identify improvement opportunities, and ensure products meet customer and regulatory requirements.

Key Responsibilities

Quality Systems & Documentation (≈60%)

• Maintain and support the company’s ISO 9001 Quality Management System
• Develop, review, and control quality documentation including:
• SOPs
• Work instructions
• Quality procedures
• Inspection plans
• Manage document control processes and ensure revision accuracy and compliance
• Assist with internal and external ISO audits, including preparation and documentation
• Track and manage Corrective and Preventive Actions (CAPA)
• Analyze quality data and generate reports to identify trends and improvement opportunities
• Support continuous improvement initiatives across departments
• Ensure compliance with customer and regulatory requirements

Manufacturing Floor Support (≈40%)

• Conduct process and product inspections on the manufacturing floor
• Perform internal quality audits and verify adherence to procedures
• Partner with production teams to resolve quality issues
• Investigate non-conformances and support root cause analysis
• Verify implementation and effectiveness of corrective actions
• Monitor production processes to ensure compliance with quality standards
• Provide guidance to operators on quality requirements and best practices

Qualifications

• Associates degree in Quality, Engineering, Manufacturing, or a related field preferred
• 1+ years of experience in a quality role within a manufacturing environment
• Working knowledge of ISO 9001 Quality Management Systems
• Experience with internal auditing, inspections, and quality documentation
• Strong analytical and problem-solving skills
• Ability to communicate effectively with both office staff and production teams
• Proficiency with Microsoft Office and quality documentation systems

Preferred Qualifications

• ISO 9001 Internal Auditor certification
• Experience with CAPA, root cause analysis tools (5 Why, Fishbone, etc.)
• Familiarity with continuous improvement methodologies (Lean, Six Sigma)

Work Environment

• 60% office environment supporting quality systems and documentation
• 40% manufacturing floor environment conducting audits, inspections, and production support
• Requires regular interaction with production teams and cross-functional departments