As a Quality Engineer at Genrobotics, you will play a crucial role in ensuring the highest standards of product quality and compliance throughout the manufacturing process. Your responsibilities will include:
Responsibilities
1. Conduct regular inspections of raw materials, components, and finished products to ensure they meet quality standards.
2. Perform in-process and final inspections during production to verify product conformity to specifications.
3. Maintain accurate and detailed records of inspections, test results, and non-conformance reports (NCRs).
4. Prepare and submit quality reports, including inspection summaries, corrective actions, and preventive measures.
5. Ensure all quality documentation complies with ISO 13485:2016 and other relevant standards.
6. Monitor production processes to ensure adherence to quality standards and identify areas for improvement.
7. Collaborate with production teams to implement corrective actions and process improvements based on quality findings.
8.
Participate in root cause analysis for defects and deviations, proposing solutions to prevent recurrence.
9. Ensure compliance with regulatory requirements, industry standards, and company policies related to quality control.
10. Assist in preparing for and conducting internal and external quality audits, including ISO 13485 audits.
11. Coordinate with regulatory affairs teams to ensure products meet global compliance standards.
12. Manage the calibration and maintenance of QC equipment and instruments to ensure accurate and reliable measurements.
13. Develop and maintain a schedule for regular calibration and equipment validation activities.
14. Participate in continuous improvement projects aimed at enhancing product quality and reducing defects.
15. Encourage a culture of quality and continuous improvement within the production and QC teams.
16. Stay updated on the latest quality control technologies and methodologies and i