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Job Location drjobs

Boulder, CO - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Position Purpose
The Quality Manager leads the Quality Assurance and Quality Engineering functions in Colorado and reports to the Director of Global Quality. Under the guidance of the Director of Global Quality the Quality Manager is responsible for assessing the current and establishing an improved and effective Quality Management System to ensure the system meets regulatory and industry standards. They utilize an extensive set of quality skills to help drive continuous improvement ensure the quality attributes of products are met and develop highly skilled teams. They monitor quality metrics and report these up to senior management. They are the primary point of contact for second and thirdparty audits and inspections testing review and disposition and customer complaints and investigations. This role forms partnerships with plant leadership to drive the success of the organization.

The Quality Manager oversees and manages the quality teams in Boulder which includes Quality Engineering and Quality Assurance for Sievers analytical instruments and consumables. The Quality Manager will be responsible for product and process quality Root Cause Analysis (RCA) and corrective actions from
manufacturing through customer issues in the field.
Duties & Responsibilities

  • Build a highperforming quality team. Mentor coach train and lead quality personnel. Perform administrative duties such as scheduling performance reviews hiring budget etc.
  • Identify and document risks and gaps for applicable regulatory ISO and/or customer requirements. Keep management informed about risks and critical nonconformities. Under guidance from the Director of Global Quality assess recommend and establish an effective Quality Management System governing manufactured products and testing laboratories.
  • Establish effective laboratory and quality processes to ensure the proper testing and release procedures are in place including maintaining effective deviation QOIs and CAPA systems.
  • Ensure that change control standardization of work training deviations CAPA complaints and audits serve organizational quality objectives and priorities. Author revise and update controlled documents such as SOPs forms and charts.
  • Ensure all requisite quality activities are executed as specified in a timely manner.
  • Ensure proper maintenance and calibration of testing equipment.
  • Oversee the review and disposition of nonconforming materials.
  • Review controlled documents change orders NPI deliverables test reports etc for Quality compliance
  • Preparation and review of clear concise audit reports that ensure mitigation of identified risks and that appropriate corrective/preventive action plans are implemented to address gaps in systems/processes and/or risks.
  • Ensure effective maintenance of Certifications and Standards including timely responses to findings and opportunities for improvements.
  • Manage change controls and variations as appropriate.
  • Investigate customer complaints using systematic methods and properly identify root cause and associated corrective and preventive actions.
  • Partner with the corporate regulatory team regarding changes in industry and regulatory standards and advise on business impact.
  • Ensure readiness of all quality activities incl. audits and inspections.
  • Influence multiple stakeholders across Quality Supply Chain Aftermarket Technology and Product Development & Application departments as well as Suppliers and Customers.
  • Use a proactive mindset and ability to work with stakeholders to identify and resolve findings with solutions that are fit for purpose and ensure sustained compliance performance.
  • Develop and report quality KPIs for instruments consumables and customer quality via a quality dashboard.
  • Develop team skills to lead certification for ISO 9001 ISO 17025 ISO 17034 and ensure product regulatory compliance for all products in all target markets.
  • Participate in proactive strategy development for the quality organization and innovate new ideas for quality improvement reporting compliance and customer satisfaction.
  • Coordinate quality improvement teams and mentor root cause corrective action investigations via a formal CAPA (Corrective Action Preventive Action) process
  • Assist director of quality in development of operational and strategic plans for the quality organization including budgeting resource needs blueprint development and prioritization of key quality programs

Qualifications :

Knowledge Skills & Abilities

  • Experience with manufacturing of analytical instrumentation.
  • Prior experience with hosting regulatory inspections and development of CAPAs to address findings and preparation of formal response.
  • Good knowledge of best Quality practices
  • Prior experience calibration and testing of analytical instruments and testing of reference standards.
  • Ability to read write and converse in the English language.
  • Must follow ISO PPE and company safety policies in the performance of job duties.
  • Proficiency with auditing process (both virtually and on site) for all external and internal quality audits.
  • Ability to influence and collaborate effectively with stakeholders at any level of the organization.
  • Analytical mind good attention to details and problemsolving skills within a structured process.
  • Concise and persuasive in the description and resolution of compliance risk.
  • 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.
  • Fluent in English spoken and written.
  • Manage and mentor college interns
  • Interface with supplier quality management to drive supplier quality improvement
  • Help develop and implement strategy for quality management system training
  • Customer site visits to observe implementation and use of analytical instrument products
  • 10 domestic travel to customer or other company sites


Required:

  • Bachelors degree in Chemistry Microbiology Mechanical Engineering Electrical Engineering  or biomedical engineering or equivalent experience in a relevant technical field
  • 5 years working with ISO 9001 regulatory testing and manufacturing requirements.
  • Demonstrated knowledge and experience in performing ISO audits.
  • Detailed knowledge of ISO 9001 standards and awareness of ISO 17025/17034 standards.
  • Data collection validation and analysis

Preferred:

  • Demonstrated knowledge establishing riskbased analysis.
  • Continuous improvement total quality control lean six sigma experience
  • Skilled in coaching development and performance feedback
  • KPI and dashboard development and reporting


Additional Information :

At Veolia we realize diverse teams make smarter decisions deliver better results and build stronger
communities. Were 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 candidates 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: $120000 $140000 USD
  • 10 Annual Incentive Plan Bonus 
  • Medical Dental & Vision Insurance Starting Day 1!
  • Life Insurance
  • Paid Time Off
  • Paid Holidays
  • Parental Leave
  • 401(k) Plan 3 default contribution plus matching!
  • Flexible Spending & Health Saving Accounts
  • AD&D Insurance
  • Disability Insurance
  • Tuition Reimbursement

This position is expected to stay open until May 15 2025. Please submit your application by this date to ensure consideration.


Disclaimer: 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. H1B visa) for this opportunity****

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.

All your information will be kept confidential according to EEO guidelines.

As an inclusive company Veolia is committed to diversity and gives equal consideration to all applications without discrimination.


Remote Work :

No


Employment Type :

Fulltime

Employment Type

Full-time

Company Industry

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