Site Lead Quality Manager & Regulatory Affairs (QM/RA)

The Role
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.

• Knowledge of the relevant norms, standards and technical rules
• Experience with moderation, mediation, conflict resolution
• Strong knowledge of ISO 9001 and relevant regulatory requirements.
• Experience in production quality management.
• Auditing and certification experience (internal and external).
• Proficiency with quality tools and MS Office.
• Completed training in engineering or comparable fields
• Relevant industry, production technology and product-related know-how
• MS Office skills
• Wide repertoire of methods in the field of quality tools
• Analytical, structured, independent, and detail-oriented.
• Strong communication and team coaching skills.
• Ability to lead local quality initiatives and motivate the team.