Site Quality Manager

Location: Lebanon, TN
 

JOB DESCRIPTION

The Site Quality Manager reports to the Director Operational Quality and is responsible for directing the site’s Quality Assurance/Quality Control activities related to the Quality Management System. This position contributes to the development and execution of the site’s QMS, metrics and continuous improvement activities in a lean, ISO 9001 manufacturing environment. Knowledge of commonly used concepts, practices and procedures within the field are required. The position relies on experience and judgment to plan and accomplish goals. A certain degree of creativity and latitude is required while performing a variety of complex tasks.

Responsibilities:

  • Management Representative with responsibility and authority to ensure Quality Management Systems (QMS) requirements are established, and effectively and efficiently maintained.
  • Applying continuous improvement methodology to drive prevention of quality nonconformance and deviations, reduced variation in product and process, improved customer satisfaction, and operational excellence across the site.
  • Preparing for, managing, and following up on quality and regulatory audits conducted by external agencies, notified bodies, customers, and internal functions.
  • Guiding the plant and business with appropriate risk-based decision making around deviations and change control.
  • Developing the team to deliver solutions for highly complex and multi-faceted problems, which require ingenuity, creativity, innovation, and strong analytical skills.
  • Proactively creating cross-functional collaboration and engagement to more effectively implement programs and processes to meet the site’s plans and objectives.
  • Establishing leadership and shared ownership for the Quality Culture within the site organization.
  • Direct and lead a team of 5-10 quality engineers, specialists, and technicians.
  • Develop and maintain appropriate staffing levels with properly trained personnel and ensure ongoing staff development to expand competence and skill set of teams members.
  • Ensure product quality at the site.
  • Conduct internal audits of the quality management system to ensure compliance with ISO, environmental, 5S, and safety standards.
  • Ensure product traceability is maintained during all stages of the production, warehousing, and shipping process.
  • Ensure a safe, clean, and healthy working environment in compliance with all safety guidelines.
  • Work in compliance with all safety guidelines
  • Maintain assigned areas to standards as dictated by 5S practices.
  • Other duties and responsibilities as assigned.

Requirements:

  • Bachelor’s degree or higher in a science or engineering discipline.
  • Five (5) years leadership experience.
  • Proven ability to lead cross-functional teams and create excellent collaboration.
  • Proven ability to lead audit activities.
  • Experience leading continuous improvement projects.
  • Excellent communication skills (oral, written, and presentation.)
  • Change Management experience of programs with significant strategic importance.
  • Demonstrated skills in customer experience management.
  • Ability to utilize MS Office applications Word, Excel, Adobe Acrobat, and manufacturing ERP application software.
  • Occasional (10-20%) travel required.
  • Quality or Regulatory leadership experience in medical device or pharmaceutical industry.
  • ASQ certification.
  • Advanced knowledge and skills using Microsoft Office suite.
  • Bilingual, specifically English and Spanish.
  • Software Quality experience.

Apply using the form below.

 

Contact Info

CCT Global Headquarters
135 Constitution Boulevard
Franklin, Massachusetts 02038
+1 (800) 370-8566

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