Quality & Compliance Lead: RCCA & Training

Arvato; Shepherdsville (KY); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company matching

Paid time off

Job summary

Arvato is seeking a Lead Quality & Training Specialist to drive the corrective action system and ensure compliance with ISO9001/13485 and CSRs. You will lead RCCA investigations, coordinate cross-functional audits, and train personnel on corrective actions to sustain certifications.

In this role, you will collaborate with Operations and Quality, analyze root causes, and improve processes through systematic problem solving.

Qualifications

• Bachelor’s degree or equivalent work experience.
• 5 Years' experience in Quality Management or a leadership role.
• Knowledge of core quality system principles including PPAP, SPC, APQP, and Root Cause/Corrective Action methods.
• Six Sigma/Lean experience preferred.
• Experience with ERP Systems (i.e. SAP) and quality management tools.

Responsibilities

• Develop, launch, and maintain the Corrective Action System to meet ISO9001/13485 and CSRs.
• Review documented processes against corrective action plans and RCCA documentation.
• Support across departments to ensure effectiveness of corrective actions and routine audits.
• Lead cross-functional meetings and facilitate ROOT CAUSE/ corrective action activities.
• Provide problem-solving input to Operations and Quality during RCCA investigations.
• Coordinate RCCA Report meetings and maintain the corrective action tracking system.
• Assist in surveillance of third-party quality system audits and maintain certifications.
• Lead audits and follow up on open issues as required.
• Present open issues to responsible parties and ensure timely closure.
• Provide training on Corrective Action procedures and participate in Management Review.

Skills

Quality Management

RCCA

Root Cause

5-Why

PDCA

Six Sigma

Lean

MS Office

SAP

Master Control

Education

Bachelor’s degree or equivalent

Tools

SAP

Master Control

Job description

Arvato is seeking a Lead Quality & Training Specialist to drive the corrective action system and ensure compliance with ISO9001/13485 and CSRs. You will lead RCCA investigations, coordinate cross-functional audits, and train personnel on corrective actions to sustain certifications.

In this role, you will collaborate with Operations and Quality, analyze root causes, and improve processes through systematic problem solving.