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 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.
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.