Quality Management Systems Specialist

Veolia Environnement SA•Boulder, CO

22h•$80,000 - $105,000•Onsite

About The Position

Our 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.

Requirements

Quality Assurance and/or Lean Six Sigma Certification
Certified lead auditor ISO 9001:2015 and working experience as an ISO internal auditor
Project planning and organization
Working experience of developing QMS documents, procedures, and working instructions
Experience in problem solving methodologies such as PDCA (Plan Do Check Act), root cause corrective action (RCA and CAPA), etc.
Knowledge and application of quality concepts such as Lean Manufacturing, 5s, Six Sigma, ISO 9001:2015, ISO 17025:2017, ISO 17034:2016 standards
Cross organizational collaboration and influencing decisions
Cross organizational business prioritization in a global team environment
Proficient in Google Suite applications and common AI tools. Business software systems commonly used such as SAP, Salesforce, and Tableau.
Effective and engaging presentation skills
Written and oral communication skills
Strong background in manufacturing
Bachelor’s Degree in engineering, systems management, measurements, or related sciences field or at least 5 years’ quality management systems experience
Applicants are required to be eligible to lawfully work in the U.S. immediately; employer will not sponsor applicants for U.S. work authorization (e.g. H-1B visa) for this opportunity

Nice To Haves

Experience managing or maintaining QMS compliance in a regulated industry such as ISO 9001 or cGMP
Internal and/or external lead auditing experience for ISO 9001 or ISO 13485 standards
Project management skills

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
Support QMS alignment with other company programs and management system
Coordinate QMS internal and external audits
Administrator for QMS related business systems such as QMS document control, QMS record controls, and QMS learning management
Develop and facilitate QMS training plans
Manage the QMS Corrective Actions process and confirm effectiveness
Develop, implement, maintain and improve quality assurance systems, including tools, policies, training and processes
Assist problem solving team and participate in continuous improvement initiatives
Manage quality data for accuracy and report generation
Ensures processes for products and services conform to established company, customer, and regulatory requirements
Supports product compliance regulations (RoHS, REACH, Conflict Minerals, etc.) and documents compliance for customer inquiries
Reviews, analyzes and reports on quality discrepancies related to processes
Improves training and auditing along with following 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.