What are the responsibilities and job description for the Quality Management Systems Specialist position at ICONMA?
Our Client, a Business Manufacturing And Supply company, is looking for a Quality Management Systems Specialist for their Oneonta, NY location.
Responsibilities :
- This position is responsible for performing change controls, creating and updating quality management procedures, managing records, and performing internal audits in compliance with the Quality Management System.
- Assists with the analysis of data for quality management system metrics, regulatory activities and supports quality management system projects and tasks.
- Generates, reviews, and maintains division level quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
- Initiates Change Controls and Document Change Requests to update procedures and processes. Collaborates with manufacturing and distribution sites to assess the impact of changes to site level processes.
- Assists with monitoring and assessing quality system metrics to ensure maintained compliance.
- Acts as a lead auditor for division internal audit program.
- Assists with completing quality projects and uses root cause analysis to assist in the completion of CAPAs.
- Supports or leads continuous improvement initiatives for quality management system processes.
- Assists with regulatory activities.
- Other duties as required.
- This position is to assist with a major project in Oneonta with changes to the documentation system and preparing for an audit.
