Quality Management Systems, Lead (25942)

Summary

Support and improve policies and procedures to the company's quality systems.

Job Responsibilities

• Provide support to maintain the Quality Management System in accordance with the standards required by the industry (ISO 13485 / ISO 9001).
• Provide support to the internal quality audit program (Lead auditor and/or auditor)
• Supervise and control the results of audits by external bodies related to product quality.
• Follow-up on corrective and preventive actions (CAPA).
• Performs process compliance audits.
• Control of the document control system.
• Ensure compliance with QMS policies and procedures.
• Induction Support (regarding Quality Management systems)

Job Essentials

• Ensure the implementation of all relevant procedures described in the Quality Management System
• Control of company documents such as manuals, procedures, instructions, policies, formats (registrations, cancellations and updates)
• Review of the actions of the scheduled audits
• Review of CAPAs (formatting and verification of effectiveness)
• Weekly follow-up to LAYERS/Customer Complaints
• Support in the analysis of the findings of external audits and the implementation of corrective and preventive actions
• Support for audits by regulatory agencies

Marginal Elements of Work

• Participation/support in external audits
• Support in answering assessments (questionnaires) sent by the client
• Audit of records used in the different areas
• Detect, inform, help develop and implement improvement actions
• 5s in the workplace