Perform routine inspections and measurements on products to ensure they meet quality specifications.
Use measurement tools (e.g.,calipers, micrometers) to check dimensions and product appearance.
Identify and report any discrepancies, non-conformities, or defects in the products.
Documentation Control:
Assist in the documentation of all quality-related records (inspection reports, test results, batch records).
Ensure all documents are accurately maintained and ready for internal audits and regulatory reviews.
Support the document control process by following SOPs for filing and organizing quality documentation.
Support for Quality Control Procedures:
Assist in implementing quality checks based on the QMS and SOPs.
Ensure that all products are consistently meeting the required specifications during each production stage.
Review and document inspection results and provide feedback for continuous improvement.
Internal Audit Assistance:
Support the preparation for internal audits in line with the ISO 13485 certification process.
Assist in audit readiness, ensuring that all necessary documentation and records are in place.
Identify areas for improvement and collaborate with the team to implement corrective actions
Communication with the Team:
Effectively communicate any quality issues or non-conformities identified during inspections to the production team or management.
Work closely with cross-functional teams to ensure that corrective actions are taken on time and that any quality-related problems are addressed promptly.
Product Knowledge & Training Support:
Stay up-to-date with product specifications and quality standards.
Support the training of new team members on quality procedures and standards.
Collaborate with the QA/QC & Regulatory Compliance Manager to enhance quality assurance processes.