Position SummaryOur Analytical Solutions product line business has an exciting opportunity available for a Quality Management System (QMS) Specialist. The QMS Specialist will be responsible for managing all aspects of site-wide ISO compliance efforts including, 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. Coordinates site-wide customer and third-party compliance audits. Make recommendations for corrective actions and risk reducing measures, based on trends in audit findings.
Key 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 documentsSupport QMS alignment with other company programs and management systemCoordinate QMS internal and external auditsAdministrator for QMS related business systems such as QMS document control, QMS record controls, and QMS learning managementDevelop and facilitate QMS training plansManage the QMS Corrective Actions process and confirm effectivenessDevelop, implement, maintain and improve quality assurance systems, including tools, policies, training and processesAssist problem solving team and participate in continuous improvement initiativesManage quality data for accuracy and report generationEnsures processes for products and services conform to established company, customer, and regulatory requirementsSupports product compliance regulations (RoHS, REACH, Conflict Minerals, etc.) and documents compliance for customer inquiriesReviews, analyzes and reports on quality discrepancies related to processesImproves training and auditing along with following up with process owners for lean, focused improvements while leveraging the Plan-Do-Check-Act (PDCA) cycleComply with all company policies including inclusion and diversity, quality, and environmental, health, and safety.