ISO/GMP Coordinator North America
Job Location: Kansas City
Title: ISO/GMP QMS Coordinator, North America
Company: DeLaval
Location: Onsite in Kansas City, MO
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.
In Support of Our Amazing Team, We Offer- Competitive compensation
- Year-end bonus
- Paid vacation plus additional time off at the end of the year
- 401(k) with company match
- Medical, Dental, and Vision benefits
- Work-life balance
- Professional development opportunities
- And MORE!
Key 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.
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.
Preferred Qualifications- 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
If you are passionate about quality, continuous improvement, regulatory compliance, and building systems that drive business success, we encourage you to apply.
Quality
