Qms & Product Regulatory Compliance Specialist

Job Description
Position Purpose
The Quality Management System (QMS) and Product Regulatory Compliance Specialist will be responsible for managing all aspects of site-wide ISO compliance efforts including, leading, and facilitating external and internal audits of the quality management system and product regulatory compliance. A key interface with operations, engineering, manufacturing, supply chain, logistics, customers, vendors, and third-party compliance partners to ensure quality management systems requirements are met. The person in this role must have the ability to develop training materials to continually improve an ISO certified site. Evaluate risk to the organization and its customers by auditing product quality plans, product design and development records, and other QMS related documented information. Lead site-wide customer and third-party compliance audits. Make recommendations for corrective actions and risk reducing measures, based on trends in audit findings. This position requires a keen attention to detail and the ability to work with individuals in all departments. This role is a hybrid position.
Duties &
Responsibilities
Lead the development, implementation, and improvement of Company’s QMS to maintain compliance to ISO requirements (ISO 9001, ISO 17025, and ISO 17034)
Author, review or revise QMS relevant controlled documents
Release of company wide controlled documents and Change Order implementation protocols
Support QMS alignment with other company programs and management systems
Coordinate and lead QMS internal and external audits and manage the QMS Corrective Actions process and confirm the effectiveness
Address customer desk audits/questionnaires, certification requests, and general quality inquiries
Partner with Engineering to define and complete product regulatory compliance of all new products and lead on-going product regulatory compliance for sustaining products as regulations change
Additional responsibilities include but are not limited to:
Ensures processes for products and services conform to established company, customer, and regulatory requirements
Reviews, analyzes and reports on quality discrepancies related to processes
Administrator for QMS related business systems such as QMS document control, QMS record controls, and QMS learning management
Improves training and auditing and follows-up with process owners for lean, focused improvements while leveraging the Plan-Do-Check-Act (PDCA) cycle
Comply with all company policies including inclusion and diversity, quality, and environmental, health, and safety.