ISO/GMP Coordinator North America

DeLaval•Kansas City, KS

4d•Onsite

About The Position

At DeLaval, we have been driving progress in milk production for more than 140 years by developing innovative solutions for dairy producers worldwide. Working with our dealer network across North America, we provide integrated milking systems, consumables, and services that help dairy producers improve animal welfare, food safety, profitability, and operational efficiency. We are seeking an experienced ISO/GMP QMS Coordinator to lead and maintain our Quality Management System (QMS) across North America. This role is responsible for ensuring compliance with ISO 9001, GMP/FDA 21 CFR Part 211 requirements, and other applicable standards while driving continuous improvement, operational excellence, and customer satisfaction.

Requirements

Bachelor's degree in Engineering, Business, Science, or a related field required.
Minimum of 7-10 years of experience in quality management, quality systems, or regulatory compliance roles.
Strong working knowledge of ISO 9001 Quality Management Systems and GMP/FDA 21 CFR Part 211 requirements.
Experience leading internal and external audits, certification activities, and regulatory inspections.
Proficiency with quality management tools and methodologies such as FMEA, SPC, 8D, CAPA, root cause analysis, and risk management.
Strong leadership skills with the ability to influence, motivate, and drive change across cross-functional teams.
Excellent written and verbal communication skills, including experience developing procedures, training materials, and management reports.
Demonstrated success leading continuous improvement and operational excellence initiatives.
Strong analytical and problem-solving skills with exceptional attention to detail.
Ability to manage multiple priorities and work effectively in a fast-paced environment.
Ability and willingness to travel as needed for audits, training, and multi-site support.

Nice To Haves

ISO 9001 Lead Auditor certification
Six Sigma Green Belt or higher certification
Experience supporting multi-site manufacturing or production environments
Knowledge of quality planning, process validation, and risk-based quality management systems

Responsibilities

Own, maintain, and continuously improve the Quality Management System (QMS), ensuring compliance with ISO 9001, GMP/FDA 21 CFR Part 211, and other applicable standards.
Lead internal audits, coordinate external audits, and ensure ongoing certification readiness across multiple facilities.
Develop, implement, and maintain Standard Operating Procedures (SOPs) to standardize processes and support regulatory compliance.
Monitor and analyze quality and process performance data to identify trends, risks, and opportunities for improvement.
Lead root cause investigations and implement Corrective and Preventive Actions (CAPA) to address nonconformities and prevent recurrence.
Provide training and coaching to employees at all levels on quality systems, regulatory requirements, and best practices.
Manage ISO 9001 and GMP/FDA certification activities from preparation through successful audit completion.
Partner with Operations, Engineering, Supply Chain, Production, and other departments to integrate quality requirements into business processes.
Ensure compliance with safety, environmental, and regulatory requirements during all quality-related activities.
Support production teams by providing guidance on quality standards, procedures, and continuous improvement initiatives.
Maintain quality records, documentation, and reporting systems to support regulatory and customer requirements.
Lead and support continuous improvement projects focused on quality, efficiency, and customer satisfaction.
Promote a culture of quality, accountability, and operational excellence throughout the organization.
Ensure the organization remains current with evolving regulatory and industry requirements.