Responsible for managing and continuously improving the site’s quality management and regulatory processes, ensuring product quality and compliance with ISO 9001 and relevant regulatory requirements.
Duties & Responsibilities
Local Responsibilities:
- Manage the site’s Quality Management and Regulatory Affairs department.
- Maintain, improve, and audit the site’s quality management system (ISO 9001).
- Develop and implement processes to ensure product and regulatory compliance.
- Coach and support site employees on quality and regulatory matters.
- Monitor quality defects and support implementation of corrective and preventive actions.
- Plan and execute internal and external audits.
- Act as the site representative for customers and auditors regarding quality and compliance.
- Support site document control and change management processes.
- Support adoption of Exaktera-wide quality standards as directed by the Global Responsible QM/RA.
Exaktera related responsibilities:
- Support adoption of Exaktera-wide quality standards as directed by the Global Responsible QM/RA.
- Support in the development of Exaktera's quality strategy and goals
- Collaborate with all other QM/RAs executives from Exaktera locations
- Strategic design of the quality site concept and harmonization with the Exaktera processes
- Development of methods and measures to ensure compliance with defined quality standards (KPIs)
- Assist in handling compliance requests from stakeholders
- Planning and implementation of internal cross-site audits
- Release local quality processes, procedures, and documentation.
- Support corrective and preventive actions at the site.