SUMMARY: Provides hands-on quality expertise and leadership in the development and execution of plans to establish and sustain industry leadership in OEM product quality and reliability. As a member of the global Tecan quality and regulatory organization, ensures the local organization’s compliance with Tecan’s regulatory strategy. Manage, control and direct the activities of the local Quality Department. Ensures that the department interfaces with key functional groups (R&D, Engineering, Manufacturing, Marketing) to drive company-wide or cross-departmental initiatives. Acts as the Quality Management Representative for the site, responsible for the efficacy of the established quality system and ensuring that it meets or exceeds all applicable standards and regulations.
Reports to: Director of Quality Assurance and Regulatory Affairs, Tecan Systems; Regional General Manager
Align with Site manager and related Line managers
1. Responsible for achieving goals set with local Director of Quality Assurance and Regulatory Affairs, Tecan Systems
2. Leads the local QA organization including QC, Documentation Control, QE, etc.
3. Performs internal QA training.
4. 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.
5. Technical advisor to Quality, R&D and Manufacturing engineering including directives in regulatory issues to project teams.
6. Coordinates and facilitates external supplier audits as needed.
7. Responsible for and ensures the global quality policy is understood, implemented, and maintained at all levels of the organization through an adequate organizational structure to ensure that products are designed and produced in accordance with the requirements of the Quality System Regulation and current ISO standards.
8. Responsible for the implementation and continuous improvement of Quality Management System and Product Quality.
9. Will be Implements and maintains Quality Management System according to ISO 13485;
10. Tecan- PMAS liaison with external and internal auditors such as BSI, customers, FDA and global Tecan quality audit.