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QMS & Product Regulatory Compliance Specialist

Company: Veolia North America
Location: Boulder
Posted on: June 8, 2024

Job Description:

Company DescriptionThe Water Technologies and Solutions, Analytical Instruments product line business has anopportunity for a QMS & Product Regulatory Compliance Specialist in Boulder, Colorado.Job DescriptionPosition PurposeThe 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 changeAdditional 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.QualificationsKnowledge, Skills, & Abilities
      • Quality Assurance and/or Lean Six Sigma Certification
      • Certified lead auditor for ISO 9001:2015
      • Working experience as ISO internal auditor
      • 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, 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
      • Knowledge of product compliance regulations (EMC, safety, low voltage directive, RoHS, REACH, WEEE, Conflict Minerals, SDS etc.)
      • Cross organizational collaboration and influencing decisions of others
      • Cross organizational business prioritization in a global team environment
      • Proficiency in Google Suite applications and business software systems, such as SAP, Salesforce, and Tableau
      • Proficient in online QMS platforms and ability to instruct teams on their use
      • Effective and engaging presentation skills
      • Written and oral communication skills
      • Tenured background in manufacturing
      • Excellent quality and product regulatory compliance skills
      • Experience to be part of a high performing quality team to ensure regulatory compliance in an exciting, fast-paced business
      • Develop and lead compliance to international quality standards and product regulatory requirements
      • Lead change throughout the business, partner cross-functionally to innovate new ideas, identify best practices, and implement best-in-class quality programs
      • Strong root cause analysis and CAPA (Corrective Action/Preventive Action) skillsCore QualificationsRequired:
        • Bachelor's Degree in engineering, systems management, measurements, or related sciences field
        • At least 5 years' quality management systems and product regulatory compliance work experiencePreferred:
          • 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 skillsAdditional InformationWorking Environment and Physical DemandsThe working environment and physical demands described here, as well as the essential functions and responsibilities noted above, are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
            • Continuously reading documents, emails, blueprints.
            • -Ability to sit, stand, and walk for extended periods.
            • Less than 10 % travel required.Veolia Water Technologies & Solutions (VWTS) is a worldwide leader in water recovery, treatment, and reuse. We design, supply, and service a range of water systems and monitoring equipment in industries ranging from pharmaceutical to food and beverage applications, and from microelectronics ultrapure water to municipal water and industrial wastewater treatment. We are one of the world's leading manufacturers of total organic carbon (TOC) analyzers and corresponding certified reference materials. Our ground-breaking endotoxin analyzer is the latest addition to our expanding analytical instruments portfolio. We strive to provide not only superior technology and design, but also outstanding quality, service, and application support.Why You'll Love Working Here!
              • In diversity lies strength - We strive to be a workplace that is inclusive and empowers people to contribute their best
              • Recognition and rewards for your hard work and achievements
              • Opportunity for new challenges - We are growing and love to promote from within
              • An excellent leadership team and a collaborative culture that values innovation
              • At all levels of the organization, we recognize talent and want to help you build your sustainable career!At Veolia, we realize diverse teams make smarter decisions, deliver better results, and build stronger communities. We're an organization that champions diversity and inclusion at every rung of the ladder and are proud to be an equal opportunity workplace. Because our people are our greatest assets, we also offer competitive compensation and -benefits that include:
                • Compensation - The salary range is tied to the market for similarly benchmarked roles. -The range is not an absolute, but a guide, and offers will be based on the individual candidate's knowledge, skills, experience, and market conditions, as well as internal peer equity. - -Depending upon all the preceding considerations for the final selected individual candidate, the offer may be lower or higher than the stated range: - -$91,000 - $110,000 annually.
                • Annual Incentive Plan Bonus: - -10%
                • Medical, Dental, & Vision Insurance Starting Day 1!
                • Life Insurance
                • Paid Time Off
                • Paid Holidays
                • Parental Leave
                • 401(k) Plan
                • Flexible Spending & Health Saving Accounts
                • AD& D Insurance
                • Disability Insurance
                • Tuition ReimbursementDisclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. The Company reserves the right to modify this information at any time, subject to applicable law.****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 thisopportunity****VWTS does not accept unsolicited resumes from external recruiting firms. All vendors must have a current and fully executed MSA on file before submitting candidates. - -Any unsolicited resumes and candidate profiles will be deemed the property of VWTS, and no fee will be due.As an inclusive company, Veolia is committed to diversity and gives equal consideration to all applications, without discrimination.

Keywords: Veolia North America, Boulder , QMS & Product Regulatory Compliance Specialist, Accounting, Auditing , Boulder, Colorado

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