Our client is a professional Medical Devices organization, based in Netherlands. This company makes products that safe lives.
Products like defibrillators, Active Medical Devices.
Design, develop, and implement policies and procedures for the maintenance, compliance and enhancement of quality and reliability standards of currently manufactured or procured components, subassemblies and products.
This includes production processes and techniques, quality engineering procedures and techniques, and regulatory compliance.
Design and supervise construction, verification, documentation and application of custom inspection and test equipment. Monitors products, processes and projects and recommends changes to improve operating efficiency.
Responsibilities relate to all products manufactured by the company.
Assure compliance to in-house and / or external specifications and standards, such as GMPs and ISO regulations
Represent quality on various business teams to support product and process improvement.
Plan, write, modify and assist in the implementation of quality and reliability requirements and procedures within the distribution area
Perform analysis and identify trends in finished products, in-process materials and recommend corrective actions and process improvements
Participate in the CAPA process as either CAPA or task owner / contributor as appropriate and necessary
Establish plans for improvement of quality and reliability to meet product objectives. Coordinate activities of Engineering, Service, Distribution and Quality Assurance
Plan and schedule quality and reliability activities such product or process audits, Quality Engineering systems activities, agency certification, computer software, and test equipment and test protocol
Manage the non-conforming products, and ensure that they are properly identified, segregated and recorded in the systems.
Handle the disposition of these non-conforming products, and follow-up on the necessary actions.
Provide support to the complaint handling team for complaint receipt and investigations. Manage the customers returns relating to product complaints and work with the Complaint Handling Team on the necessary actions around those returns.
Provide direction to Operations and the warehouse to ensure that workmanship standards, acceptance criteria, and general quality policies are met.
Provide support for the development, execution and reporting of field actions in the EMEA region.
Perform other related duties as assigned
Bachelor of Science degree in an engineering discipline or equivalent experience with advanced study in the quality sciences and business management disciplines
5 years experience in an electronic manufacturing environment with three years directly involved in quality engineering
3 years experience in the medical devices industry or similar regulated industry
Excellent English language communication skills using both written and verbal method