Overview Quality Engineer role at Teknor Apex Company. The position focuses on quality management system implementation and continuous improvement across the organization.
Responsibilities - Develop, implement and maintain QMS documentation to maintain compliance with applicable standards such as ISO 9001, ISO 13485 or GMP
- Monitor regulatory changes and update the QMS accordingly
- Conduct internal audits and support external audits (external auditing bodies, suppliers and customers)
- Analyze quality data and metrics to identify trends and areas for improvement
- Collaborate with cross functional teams to ensure that the quality standards are integrated into processes
- Lead and support Management Review and action items related to the QMS
- Coordinate with Certification Bodies as the point of contact for quality system certifications
- Coordinate with Operations and Technology to address product quality iss...