Quality Manager

1 day ago

Batavia, United States CCL Label Full time
Job Highlights

  • Conducts supplier audits, subcontractors and internal audits (QMS and cGMp)
  • Manages customer audits and required follow-up (QMS and cGMP)
  • Analysis of technical quality agreements
  • Manages continuous improvement activities
  • Standardizes and updates the established Quality Systems (procedures)
  • Manages non-conformances, internal and external
  • Develops and manages training schedule and brings ideas for improvement
  • Maintains training documentation
  • Ensures the proper management of the preventive maintenance and validation program
  • Manages the change control program (Impact Analysis)
  • Prepares and conducts regular quality meetings (KPI) and management reviews
  • Attends management meetings
  • Manages the corrective action program (CAPA) and oversees its implementation and effectiveness
  • Responds to external CAPAs and complaints from customers
  • Serves as sales support for customer surveys, questionnaires, new product review and tours/visits
  • Participates in the interviewing and hiring of staff
  • Evaluates Quality Department and other employees
  • Final order review
  • Proof approvals-internal and external
  • First article approvals for all orders
  • In-process inspection
  • Manages internal audit schedule covering all SOP/Quality Systems
  • Develops and maintains SOPs including document control, review and re-write
  • Supports pressroom with technical and quality decisions
  • Performs other related duties, as needed
Job Summary & Requirements
  • Bachelor’s and/or Master’s degree in Management or related field or relevant experience
  • Strong time management skills and attention to detail
  • Previous experience in a manufacturing environment preferred
  • Fully understands cGMP in the Healthcare segment
  • Knowledge of validation programs with IQ, OQ, PQ
  • Safety Conscious
  • Microsoft Excel, Word, Outlook, Presentation
  • SOP Development Implementation
  • Fully understands Lean Manufacturing, including but not limited to 5S practices, as part of a continual improvement method
  • Qualified to run and implement Kaizen methodology
  • Strong decision-making skills Intermediate math skills including statistical inference, fractions, percentages, ratios, and proportions
  • Ability to speak effectively before groups of employees
  • Ability to adapt and manage priorities Demonstrate discipline, interpersonal leadership skills
  • Strong report letter writing skills
  • Ability to work in and promote a team environment

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