Quality Assurance Coordinator

Bertelsmann-JobsPleasant Prairie, WI

About The Position

In the position of Quality Coordinator you provide support in achieving and maintaining the required operational quality levels and support with audits and certifications. Together with your team you make sure the customer requirements and KPI’s are in place and you strive to improve the quality scores. This position is responsible for collecting, maintaining, and distributing all documents and communication relevant to compliance with Arvato’s Corrective Action/CI System(s), including but not limited to: internal/external audit non-conformances, customer complaints, internal process compliance, objective evidence/verification of closed CARs, etc. Position is responsible for ensuring that applicable rules and regulations, including but not limited to corporate requirements, internal procedures, and customer specific requirements are fully implemented, documented and supported by evidence as required. Ensure the development, launch and maintenance of the Arvato’s Corrective Action System to meet or surpass requirements of the ISO9001 (Or 13485) international standard and associated customer specific requirements (CSRs). Review of Documented Processes (key procedures) per ISO9001 (Or 13485) and CSRs against corrective action plans as planned through RCCA documentation to ensure safe, timely, and effective implementation. Assist the development/enforcement of the quality systems within all departments (at all levels) by ensuring effectiveness of corrective actions through follow-up and routine audits. Lead cross-functional meetings & facilitate teams as needed in the preparation and execution of effective Root Cause/Corrective Action activities. Provide detailed problem-solving expertise to Operations and Quality in Root Cause investigations Responsible for coordinating and chairing cross-functional RCCA Report meetings. Maintain Corrective Action tracking system/database and ensure prompt communication with all parties involved. Assist in the preparation of the surveillance of 3rd party quality systems audits to maintain certifications. Lead audits where appropriate and follow-up with open issues as required. Present relevant open issues to responsible parties and ensure prompt follow-up closure. Provide training to Arvato personnel on Corrective Action procedures. Provide valuable analysis and actionable input to Management Review regarding effectiveness/efficiency of Arvato’s Corrective Action System. Actively participate in presentations to management and the customer as required. Be a member of cross-functional teams to focus on problem solving and continuous improvement and complete action plans as delegated by the team. Assist in development of Turtle Diagrams, Management System requirements and potential changes to regulatory standards (i.e., ISO9001, ISO14001, ISO13485, OSHA, etc.)

Requirements

  • High School Diploma or Equivalent.
  • Good knowledge of English is essential.
  • 5+ years of experience in quality assurance.
  • Effective analytical and problem-solving skills.
  • Good communication skills and the ability to work collaboratively across teams.

Responsibilities

  • Achieve and maintain required operational quality levels.
  • Support with audits and certifications.
  • Ensure customer requirements and KPI’s are in place.
  • Improve quality scores.
  • Collect, maintain, and distribute all documents and communication relevant to compliance with Arvato’s Corrective Action/CI System(s).
  • Ensure implementation, documentation, and evidence of applicable rules and regulations.
  • Develop, launch, and maintain Arvato’s Corrective Action System to meet or surpass ISO9001 (Or 13485) and associated customer specific requirements (CSRs).
  • Review Documented Processes per ISO9001 (Or 13485) and CSRs against corrective action plans.
  • Assist the development/enforcement of quality systems within all departments.
  • Lead cross-functional meetings & facilitate teams in the preparation and execution of effective Root Cause/Corrective Action activities.
  • Provide problem-solving expertise to Operations and Quality in Root Cause investigations.
  • Coordinate and chair cross-functional RCCA Report meetings.
  • Maintain Corrective Action tracking system/database and ensure prompt communication.
  • Assist in the preparation of the surveillance of 3rd party quality systems audits.
  • Lead audits where appropriate and follow-up with open issues.
  • Present relevant open issues to responsible parties and ensure prompt follow-up closure.
  • Provide training to Arvato personnel on Corrective Action procedures.
  • Provide analysis and input to Management Review regarding effectiveness/efficiency of Arvato’s Corrective Action System.
  • Participate in presentations to management and the customer.
  • Be a member of cross-functional teams to focus on problem solving and continuous improvement.
  • Assist in development of Turtle Diagrams, Management System requirements and potential changes to regulatory standards.

Benefits

  • Medical, Dental, Vision, Life Insurance, and Disability Pay.
  • 401(k) with company matching up to 6%.
  • Paid Time Off, including paid holidays.
  • Flexible Spending Accounts.
  • Voluntary benefits such as legal and financial assistance, pet insurance, and more.
  • Employee Assistance Program.
  • Ongoing employee development opportunities including tuition reimbursement, scholarships, and training.
  • Commuter benefits.
  • Employee engagement activities.
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