Quality Assurance Coordinator

About the role

The Quality Assurance Coordinator provides support in achieving and maintaining the required operational quality levels, supports with audits and certifications, and ensures 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).

Responsibilities

• 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.
• Aid in 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.
• Aid 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.
• Aid in the development of Turtle Diagrams, Management System requirements and potential changes to regulatory standards (i.e., ISO9001, ISO14001, ISO13485, OSHA, etc.)

Qualifications

• A 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.

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.