Leads the local QA organization including QC, Documentation Control, QE, etc.
Performs internal QA training.
Oversight of local quality processes including complaint handling, CAPA and internal audit. This includes the implementation of local and global procedures. Establish metrics that indicate success and opportunities for improvement.
Technical advisor to Quality, R&D and Manufacturing engineering including directives in regulatory issues to project teams.
Coordinates and facilitates external supplier audits as needed.
Responsible for the implementation and continuous improvement of Quality Management System and Product Quality.
Implements and maintains Quality Management System according to ISO 13485;
Liaison with external and internal auditors such as BSI, customers, FDA.
Yêu Cầu Công Việc
A Bachelor’s degree in an engineering or related scientific discipline or equivalent experience required.
Experience in Metal Precision Matching Assembly, or life sciences environment is required.
Experience in CMM- Coordinate Measuring Machine
Must have thorough understanding of GxP requirements as they relate to medical devices, regulatory compliance and statistical reporting.
Project leadership capability and ability to drive culture change.
Experienced in Certificate ISO 9009:2015, ISO 13485