Quality Manager

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.
• Support development of Exaktera's quality strategy and goals.
• Collaborate with all other QM/RA 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.

Local Responsibilities (core focus):

• 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/RA 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.

• 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, preferred 2-5 years.
• 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 experience.

• 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.