ISO Coordinator - NPA Quality Assurance

Overview

NIPRO PHARMAPACKAGING AMERICAS CORP - (HQ), 1200 N 10th Street, Millville, New Jersey, United States of America

Posted Tuesday, December 2, 2025 at 5:00 AM

We believe our current and future responsibility to society is to develop innovative, value-added products and technologies that improve patient outcomes and healthcare worldwide.

Main Purpose of Job

The ISO coordinator ensures the requirements for a centralized and integrated documented Quality Management System and Environmental Health and Safety System (based on the ISO Standards) are implemented and maintained as established by Headquarters’ Executive Management. Maintain status of certified standards for revisions/changes as required for most sustainable transition.

Main Activities and End-Results Expected

• Maintain ISO certifications and ensure compliance with the latest revisions of applicable international standards
• Lead and support internal and supplier audits; coordinate registrar audits (travel required)
• Complete and maintain ISO documentation and generate monthly reports
• Exemplify all safety, health, and environmental rules, company regulations, and ISO procedures and work instructions
• Exhibit skill in internal and external auditing processes to conduct, support, and lead audits within the division and supplier audits; must be able to travel.
• Demonstrate superior organizational, coordination, and multi-tasking abilities.
• Promote teamwork across all areas
• Possess the ability to communicate, suggest, negotiate, and explain necessary improvements to the Quality Management System to maintain certifications.
• Maintain knowledge of Environmental Health & Safety requirements, including those from Government Regulatory Agencies, to ensure project compliance.
• Administer and maintain the training database for Tubing facilities, continuously improving the system to provide more convenient and accurate training records.
• Participate in root cause analysis and identify corrective actions related to audit findings within the division and among suppliers
• Ensure Management and Production personnel are trained on requirements and possess the skills necessary to implement all ISO standards
• Collaborate with customers, manufacturing, and technical service teams on continuous improvement programs to integrate into the Quality Management System, ensuring compliance with ISO standards and meeting customer specifications
• Recommend and support the implementation of necessary improvements to the Quality Management System to maintain certifications
• Coordinate with all departments to streamline documentation processes for both hard copy and electronic formats
• Train Management and Production personnel on ISO requirements through training platform (Dayforce).
• Continue to expand knowledge of ISO principles and standards in alignment with the strategic goals and objectives of the business, focusing on certifications to be achieved and maintained.
• Establish, train, and monitor Internal Audit Teams and Lead Auditors for all NPA facilities.
• Work closely with Management and Production personnel to develop and document training programs, procedures, corrective actions, internal audits, and other integrated ISO-required systems
• Adhere to the 4 C s outlined in the QMS policy: communication, commitment, continuous improvement, and customer satisfaction
• Provide technical, managerial, and marketing assistance on ISO standards as needed
• Performs other duties as assigned

• Education: High School diploma required with a four (4) year degree or equivalent experience.
  Certifications: Lead Auditor and/or Certified Quality Auditor (CQA) preferred.
• Skills/
  
  Experience:
  
  Superior organizational, coordination and multi-tasking abilities.
• Experience implementing and maintaining documented management systems, specifically ISO standards.
• Knowledge of ISO 13485:2016 (Medical devices QMS) is a plus.
• Business Knowledge: ISO Management Systems and Standards, Auditing concepts;
  Lead Auditor (Quality)/Certified Quality Auditor (CQA), Understanding of Manufacturing process, Supply Chain, Customer Knowledge/Requirements, International Standards, cGMP s and Six Sigma.
• Skills
  
  Competencies:
  
  People Management, Communications (visual, verbal & written), Change Management, Project Management, Intermediate to advanced computer skills, Supervisory, and Training.

We care:
We seek commitment. In return, as a company we are also committed to our past, present, and future colleagues.

NIPRO PHARMAPACKAGING AMERICAS CORP - (HQ), 1200 N 10th Street, Millville, New Jersey, United States of America