Quality Manager

Position Summary

The Quality Manager is responsible for the development, implementation, and continuous improvement of the site’s Quality Management System (QMS).

This role ensures compliance with ISO standards, regulatory requirements, customer expectations, and internal policies.

The Quality Manager serves as the primary site representative during external audits (ISO, FDA, RBA, NAID, R2, customer audits) and is accountable for audit readiness at all times.

This position holds authority to escalate compliance and quality risks and to stop production or distribution activities when necessary to protect the company and its customers.

Key Responsibilities

Quality Management System Ownership

• Maintain and improve the site’s ISO-compliant Quality Management System (ISO 9001, 14001, 45001 and others as applicable)
• Ensure policies, procedures, and work instructions remain current and controlled
• Oversee document control and revision processes
• Ensure alignment between documented procedures and operational execution
• Conduct management review preparation and reporting

Audit & Regulatory Leadership

• Lead internal audit program and risk-based audit planning
• Serve as primary host and point of contact for external audits (ISO, FDA, RBA, NAID, R2, customer audits)
• Coordinate audit logistics, evidence gathering, and response preparation
• Ensure timely and effective closure of audit findings
• Maintain audit readiness year-round

Compliance & Risk Management

• Monitor regulatory and standard changes and update processes accordingly
• Conduct compliance risk assessments and gap analyses
• Escalate systemic risks to site leadership
• Ensure preventive controls are implemented to avoid repeat findings

Quality Assurance & Quality Control Oversight

• Ensure quality assurance systems are effectively implemented and followed
• Verify work instructions and inspection controls are adhered to on the floor
• Drive containment actions for quality issues
• Lead root cause analysis (5-Why, Fishbone, etc.)
• Ensure corrective and preventive actions are effective and sustainable
• Partner with operations to reduce defects and nonconformances

CAPA & Continuous Improvement

• Own CAPA lifecycle from identification through effectiveness verification
• Track corrective action timelines and accountability
• Analyze quality trends and identify systemic improvement opportunities
• Support continuous improvement initiatives aligned to SQDIP goals

Training & Awareness

• Ensure required compliance and quality training is completed and documented
• Provide guidance and education to supervisors and associates on quality expectations
• Reinforce the “why” behind compliance and quality requirements
• Support development of a culture of accountability and ethical practices

Authority & Accountability

The Quality Manager has the authority to:

• Stop production or distribution activities due to quality or compliance risk
• Require corrective actions across departments
• Escalate regulatory or customer risk directly to senior leadership
• Represent the site during regulatory and certification audits

This role operates independently within the organizational structure to ensure objectivity and system integrity.

Qualifications

Required

• Bachelor’s degree in Business, Engineering, Quality, Compliance, or related field (or equivalent experience)
• Minimum 5 years of experience in compliance, quality systems, or regulatory environments
• Experience implementing and maintaining ISO 9001 or similar quality standards
• Experience leading internal and external audits
• Strong knowledge of CAPA, root cause analysis, and risk mitigation processes
• Excellent documentation control and analytical skills
• Strong communication and cross-functional leadership ability
• Proficiency in MS Office and quality documentation systems
• Bilingual (English/Spanish)

Preferred

• Experience in supply chain, manufacturing, or distribution environments
• Familiarity with RBA, NAID, R2, ISO 14001, ISO 45001
• Lead Auditor certification

Work Environment

• Primarily office-based within a manufacturing and distribution facility
• Frequent interaction with production and warehouse areas
• Exposure to operational noise and lift truck traffic
• Periodic domestic travel (up to 25%) as required