Quality Systems Representative (1st Shift)

Job Title: Quality Systems Representative     

Employment Status: Full-Time 

Classification: Non-Exempt 

Work Schedule: Day 

Reports to:  Quality Manager 

Supervisory Responsibilities: No 

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Position Summary:  The Quality Systems Representative is primarily responsible for maintaining the Quality Management System ISO and other controlled company documentation (i.e. safety, GMP), but will also assist in supporting existing and new product quality initiatives.  This includes, but is not limited to the supporting audits, product investigations, and other responsibilities as assigned in support of the Quality Management System. 

 

Essential Functions of the Quality Systems Representative

  • Develop, manage, and maintain all Quality Management System documentation to ensure compliance with ISO9001 requirements along with customer and Gusmer requirements. 
  • Process Document Change Orders in a timely manner, receiving input from the appropriate personnel and management on documentation, and coordinating necessary training on document changes. 
  • Ensure that controlled copies of documentation are maintained in necessary areas and manage red-line-system as appropriate. 
  • Coordinate review of all QMS documentation per specified review intervals, including coordination with affected personnel and management to ensure documentation remains accurate.  Coordinate follow-up training as appropriate. 
  • Provide support for customer required audits, including serving as an audit escort and participating in audit responses and follow-ups. 
  • Coordinate Corporate ISO Consistency efforts including controlling and updating all corporate documentation and the associated training and paperwork. 
  • Coordinate Corrective and Preventive Action efforts, including CA/PA initiation and assignment, follow-up activities with responsible managers, tracking for quarterly Management Review and verifying effectiveness of actions taken. 
  • Support the facilitation of Gusmer’s Good Manufacturing Practice program, collaborating with GMP team in plant audits, GMP reports, and program improvements. 
  • Support site risk assessment and validation activities as necessary. 
  • Conduct root cause analysis and help drive implementation of corrective actions for process related concerns and Nonconforming Material situations. This may include data analysis and testing as part of the investigation. 
  • Perform final review and release of work orders.  

Other Duties of the Quality Systems Representative:

  • Provide support at Quality Council at both a site and corporate level. 
  • Assist QC Lab functions as needed including First Piece Inspection process. 
  • Assist Supply Chain as directed, with incoming raw material issues/concerns. 
  • Responsible for working with many employees from all sites and functions.  This includes employees from maintenance, production, R&D, quality, engineering, warehousing, office, and management.
  • Perform other related duties as required and assigned by the Quality Manager. 

This is not meant to be a comprehensive listing of activities, duties, and responsibilities of the Quality Systems Representative.  These items may change or new items may be assigned with or without notice. 

 

Experience and Education Requirements 

  • High School Graduate or equivalent required.  Bachelor’s Degree in office administration, communications, quality system management, or equivalent experience preferred. 
  • 3-5 years of work experience in ISO9001 certified company or other highly regulated environments with some involvement in QMS. 

 

Knowledge, Skills, and Abilities (KSA’s) Required 

  • Knowledge of ISO9001 standard and implementation in a manufacturing environment. 
  • Ability to multi-task and handle variety of projects and assignments on a daily basis.
  • Ability to work well with others to ensure success of system. 
  • Ability to take requirements and concepts and convert to written instructions. 
  • Excellent organizational abilities to maintain status of 800-1200 documents, many pending changes at any given time.   
  • Intermediate/Advanced Microsoft Office word processing and spreadsheet knowledge.     

 

Physical Requirements 

The physical demands listed are representative of those that must be met by the Quality Systems Representative to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.  Modified “light duty” restrictions may be arranged as needed and when available for job-related injuries or illnesses. 

While performing the duties of this job, the Quality Systems Representative is regularly required to sit, walk, and stand; lift/carry/push/pull under 10 pounds; use hands repetitively for writing, keyboarding, and grasping/holding.  The employee is occasionally required to lift/carry/push/pull up to 20 pounds; twist/turn; reach outward and over shoulders, and bend and squat. 

Specific vision abilities required by the Quality Systems Representative includes close vision, distance vision, peripheral vision, depth perception and ability to adjust focus. 

Acute hearing is necessary for telephone and in-person communication with customers and fellow employees, and visual acuity sufficient to read a computer screen and paper documents. 

 

Working Conditions 

The Quality Systems Representative typically functions in a combination of an office and plant environment; there will be exposure to moderate noise levels, fumes, dust, chemicals, heat/cold and allergens especially in plant/warehouse environment. 

 

EEO Policy Statement: 

Gusmer Enterprises, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 

Gusmer will also consider requests for reasonable accommodations made by applicants and employees on an individualized basis, including those based on disabilities and sincerely-held religious beliefs, where such accommodations do not impose an undue burden on the business. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. 

 

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