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In the position of Lead Quality & Training Specialist, you will provide support in achieving and maintaining the required operational quality levels, as well as assisting with audits and certifications. Together with your team, you ensure that customer requirements and KPIs are in place and 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. YOUR TASKS

* Ensure the development, launch, and maintenance of 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 in the development/enforcement of the quality systems within all departments (at all levels) by ensuring the 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 the 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 the 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 the development of Turtle Diagrams, Management System requirements, and potential changes to regulatory standards (i.e., ISO9001, ISO14001, ISO13485, OSHA, etc.)

YOUR PROFILE

* Bachelor’s degree or equivalent work experience in relevant field.

* 5 Years' experience in Quality Management or a leadership role

* Working knowledge of core quality system principles, including PPAP, SPC, APQP, and Root Cause/ Corrective Action methods

* Demonstrated expertise in problem-solving methods and activities, including RCCA, 5-Why, 8-Disciplines, Deming/PDCA, and A3, and ability to coach in same.

* Six Sigma/Lean experience preferred

* Knowledge of MS Office.

* Experience with ERP Systems (I.E. SAP)

* Knowledge of FDA regulations

* Experience with quality management systems.

* ISO 13485 Internal Auditor Certification.

* Proficiency in quality management and audit tools (Master Control).

* Ability to handle multiple tasks and meet deadlines in a dynamic environment.

WE OFFER

* 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.

EOE Protected Veterans/Disability