The Company:Exaktera brings together world-class brands in lasers, LEDs, and optical systems, delivering reliable, high-performance solutions to OEMs and end-users worldwide. In industrial, medical, and machine vision markets, our technologies power progress where light matters most.With a global footprint and deep technical expertise, Exaktera provides customers with a single, trusted partner for advanced optical components, systems, and enclosures. Our brands combine decades of engineering excellence with proven application knowledge, ensuring the highest performance, reliability, and value.A position has arisen within ProPhotonix (An Exaktera Company) for a Site Lead Quality Manager & Regulatory Affairs (QM/RA)The RoleResponsible 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 & ResponsibilitiesLocal 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.Skills & Experience Required:· 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.If you are interested in this position and have the relevant skills and experience, please apply via LinkedIn.