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Veolia

Water, waste, and energy services provider

Quality Manager

Validation, Compliance & Quality SystemsPosted on Nov 12
Full-timeBoulder, CO, USA

About the Job

Requirements

  • A degree (BSc or MSc) or equivalent experience in a relevant technical field, such as chemical, mechanical, electrical, microbiology, or biomedical engineering.
  • At least 5 years of experience working with ISO 9001, regulatory, testing, and manufacturing requirements.
  • Specific experience with ISO 9001, ISO 17025, and ISO 17034.
  • Demonstrated knowledge and experience performing ISO audits.
  • Experience with continuous improvement, total quality control, and Lean Six Sigma.
  • Experience developing and reporting KPIs and dashboards.
  • Experience with manufacturing analytical instrumentation.
  • Prior experience hosting regulatory inspections, developing CAPAs to address findings, and preparing formal responses.
  • Prior experience in calibration and testing of analytical instruments and testing of reference standards.
  • Understanding of corporate governance processes.
  • Working understanding of R&D and New Product Development practices and requirements.
  • Demonstrated application of continuous improvement, change control, and risk assessment.
  • Good knowledge of quality practices and detailed knowledge of ISO 9001 standards, with awareness of ISO 17025 and ISO 17034 standards.
  • Demonstrated knowledge of establishing risk-based analysis.
  • Proficiency with auditing processes, both virtually and on-site.
  • Ability to read, write, and converse in English.
  • Ability to follow ISO, PPE, and company safety policies while performing job duties.
  • Ability to travel domestically 10% to customer or other company sites.

Responsibilities

  • Lead the Quality Assurance and Quality Engineering functions in Colorado and report to the Director of Global Quality.
  • Assess the current Quality Management System and drive improvements to ensure it meets regulatory and industry standards.
  • Drive continuous improvement, ensure product quality attributes are met, and develop highly skilled teams.
  • Monitor quality metrics and report them to senior management.
  • Support second- and third-party audits and inspections, testing review and disposition, and customer complaints and investigations.
  • Oversee the quality team in Boulder, including Quality Engineering and Quality Assurance for Sievers analytical instruments and consumables.
  • Manage product and process quality, root cause analysis, and corrective actions from manufacturing through customer issues in the field.
  • Build a high-performing quality team; mentor, coach, train, and lead quality personnel; and handle scheduling, performance reviews, hiring, and budget administration.
  • Identify and document risks and gaps against applicable regulatory, ISO, and customer requirements, and inform management about risks and critical non-conformities.
  • Under the guidance of the Director of Global Quality, assess, recommend, and establish an effective Quality Management System for manufactured products and testing laboratories.
  • Establish laboratory and quality processes for proper testing and release procedures, including maintaining deviation, QOIs, and CAPA systems.
  • Ensure change control, work standardization, training, deviations, CAPA, complaints, and audits support organizational quality objectives and priorities.
  • Author, revise, and update controlled documents, including SOPs, forms, and charts.
  • Ensure required quality activities are executed on time and as specified.
  • Ensure testing equipment is properly maintained and calibrated.
  • Oversee review and disposition of non-conforming materials.
  • Review controlled documents, change orders, NPI deliverables, test reports, and other materials for Quality compliance.
  • Ensure clear, concise audit reports are prepared and corrective/preventive action plans address identified system, process, and risk gaps.
  • Maintain certifications and standards, including timely responses to findings and opportunities for improvement.
  • Manage change controls and variations as appropriate.
  • Investigate customer complaints using systematic methods and identify root causes and associated corrective and preventive actions.
  • Partner with the corporate regulatory team on changes in industry and regulatory standards and advise on business impact.
  • Ensure readiness for quality activities, including audits and inspections.
  • Influence stakeholders across Quality, Supply Chain, Aftermarket, Technology, Product Development and Application departments, suppliers, and customers.
  • Work with stakeholders to identify and resolve findings with fit-for-purpose solutions that support sustained compliance performance.
  • Develop and report quality KPIs for instruments, consumables, and customer quality through a quality dashboard.
  • Develop team skills to lead certification for ISO 9001, ISO 17025, and ISO 17034, and ensure product regulatory compliance in all target markets.
  • Participate in quality organization strategy development and develop improvements in quality, reporting, compliance, and customer satisfaction.
  • Coordinate quality improvement teams and mentor root cause corrective action investigations through a formal CAPA process.
  • Work with supplier quality management to drive supplier quality improvement.
  • Assist the Director of Quality with operational and strategic plans, including budgeting, resource needs, blueprint development, and prioritization of quality programs.
  • Manage and mentor college interns.
  • Conduct required customer site visits to observe implementation and use of analytical instrument products.

About the Company

Veolia

Water, waste, and energy services provider

Generating company summary.

Company size
10,001+
Company stage
IPO
Headquarters
Aubervilliers, France
Founded
1853

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