Reinforce our company's commitment to excellence by joining the Quality Department as a dedicated Quality Engineer.
Key Responsibilities
* Implement and maintain quality systems adhering to international standards ISO 13485 and ISO 9001, ensuring seamless compliance with medical device regulations.
* Collaborate in product development, production trials, sampling, and runs of new materials and finished products, driving efficiency and effectiveness.
* Assist in generating validation protocols and reports, including data analysis and test scripts as required, fostering continuous improvement.
* Monitor vendors, identify potential issues, and implement controls to prevent problems from reaching company products.
* Conduct internal audits according to ISO 13485 programs, promoting a culture of quality and adherence.
Competencies
* A minimum of 2-3 years of experience in quality engineering, preferably with knowledge of validation principles and ISO 13485 medical device requirements.
* Demonstrated understanding of quality management systems, regulatory guidelines, and industry standards.
* Possess excellent analytical, problem-solving, and communication skills, with the ability to work effectively in a team environment.