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Quality System Regulatory Supervisor

Req ID: J2317824

  • Ubicación
    Gurnee, IL, Illinois, United States of America
  • Categoría Grupo de Calidad
  • Publicado miércoles, 11 de mayo de 2022
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

Descripción del Trabajo

JOB SUMMARY
In partnership with the site Quality Manager, carry out the Quality Management System function for the site.  Accountable and responsible for ensuring best practices pertaining to the use of quality tools are developed and deployed at the site.  Responsible for the management of the Quality Management System at the site including Quality planning activities.  Responsible for the development, implementation, and maintenance of the document control system.  Coordinates, plans, and executes all operational activities related to QMS compliance.  Responsible for the administration, organization, and conducting training/educational programs designed to achieve the organization’s business objectives, including promotional development, on-the-job training, employee orientation, and safety training.  This position is audit facing and provides a high level of internal and external interface with colleagues, customers, and regulatory agencies.  Executes major quality initiatives / projects at the direction of the site Quality Manager.  Investigates problems and recommends corrective actions for recurring and non-recurring discrepancies.  Creates motivating environment and empowers others.  Assists in building cohesive teams, bringing out the best from team members while fostering teamwork and collaboration. 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Identifies and manages performance through daily, weekly, monthly metrics, with clear stakeholder communication and issues elevation.
  • Applies systematic technical problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues in documentation and quality system.
  • Identifies, plans, and executes quality requirements resulting from internal and external changes.
  • Uses the Quality Management System (QMS) in developing and executing the appropriate processes for consistent, technical, risk-based decision making and continuous improvement efforts.
  • Leads the daily management and operations of the company document control system (including the creation and release of documents, drawings, and changes through the change control process).
  • Develop and maintain the organization’s QMS IT solution (e.g. NWQS, PTC Windchill, etc.).
  • Develop and implement policies, procedures, work instructions, and forms in conjunction with functional managers and technical staff.
  • Identify training, learning management, and development programs for all employees.
  • Maintain and retain quality records in accordance with procedures.
  • Design, develop, implement, and deliver training and related learning support programs to the organization.
  • Develop and implement procedures, work instructions and/or knowledge/job aids to assess and support performance improvement, learning and development programs.
  • Responsible for the tracking and preparation of periodic reports on employee learning and training.
  • Servant leader to direct reports to include establishing individual goals & objectives, provide regular performance feedback, and support employee development & training.
  • Responsible for ensuring label controls through SAP and process order generation.
  • Interfaces with internal functional stakeholders (e.g. manufacturing, engineering, work cell, supply chain, etc.) to ensure internal and customer requirements are consistently met
  • Assists in the hiring and training of departmental staff and activities to ensure high performance, accountability, interdependence, and collaboration.
  • Minimizes customer complaints due to product quality through effective corrective and preventive actions.
  • Ensure compliance of project activities to appropriate standards and regulations (FDA, ISO, etc.).
  • Support the development and/or implementation of site, customer, lean, or global quality initiatives with the use of project management methods and tools.
  • Ensure corrective actions are documented, implemented, verified effective, and submitted on time.
  • Support all company safety and quality programs and initiatives.
  • Perform other duties and responsibilities, as assigned.


EXPERIENCE REQUIREMENTS

  • Experience in creating & implementing policies, procedures, and work instructions in support of a Quality Management System.
  • Experience in developing and delivering training to individuals and groups of employees.
  • Experience in internal, supplier, third-party & FDA quality audits / inspections.  Auditing experience.
  • Able to assess and recommend continuous improvements efforts to QMS.
  • Strong knowledge of Quality Management System, 21 CFR Part 820/210/211 & ISO 13485.
  • Device History Record experience.
  • Must be able to interact with management team and regulatory bodies in a professional manner both orally and in written communication.
  • Excellent problem-solving abilities.
  • Strong analytic skills and multitasking abilities as well as identifying and resolving issues with limited supervision.
  • Strong computer skills. Proficiency in use of personal computers, Microsoft Office products (Excel, Word, and PowerPoint) and e-mail skills required.
  • Frequent sitting, standing, and walking with occasional lifting of up to 25 lbs.
  • BA/BS preferred (or equivalent work experience) with a minimum of 8 years of experience in quality related field.
  • 2 years supervisory experience.
  • Or a combination of education, experience and/or training.
  • Lead auditor certification
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