该职位来源于猎聘 Main accountabilities: Barco designs technology that makes everyday life a little better. Seeing beyond the image, we develop sight, sound, and sharing solutions to help you work together, share insights, and wow audiences. Our focus is on three core markets: Enterprise (from meeting and control rooms to corporate spaces), Healthcare (from the radiology department to the operating room), and Entertainment (from movie theaters to live events and attractions). Our solutions make a visible impact, allowing people to enjoy compelling entertainment experiences; to foster knowledge sharing and smart decision-making in organizations and to help hospitals provide their patients with the best possible healthcare. Headquartered in Kortrijk (Belgium), Barco realized sales of 804 million euro in 2021 and has a global team of 3,000+ employees, whose passion for technology is captured in +500 granted patents. Is Quality your motto? Do you want to collaborate with various departments to maintain a strong quality process and quality standard? Within our site we are looking for a 【Quality Engineer】 to join our team The 【Quality Engineer】 will oversee the quality assurance processes specifically related to the design and development of medical devices.
You will take the lead in the govenance of the continuous improvements cycles for a selected group of medical devices of our Medical Devices.
This is a global role working with stakeholders in all of our location and fiction sicu as service, product management , design & development and manufacturing. This role involves managing the Quality Management System (QMS), ensuring compliance with regulatory standards, and leading continuous improvement initiatives with main focus on the design and development phases.
- Design and Development Quality: Ensure that all design and development activities comply with ISO 13485, FDA 21 CFR Part 820, and MDR 2017/745/EU standards.
- Design Reviews: Conduct and oversee design reviews to ensure product quality and compliance throughout the development lifecycle.
- Documentation: Oversee the creation and maintenance of quality documentation related to design and development, including design history files (DHF) and technical files.
- Quality Management System: Implement and maintain an ISO 13485 compliant QMS tailored to design and development processes.
- Support the QMS activites within the sites and globally by being part of the internal audits team, supporting customer and external certification audits in the site.
- Train and coach team members on QA processes and regulatory requirements specific to design and development.
Support QMS training & coaching initiatives as well on a global level as in the sites.
- Product Quality and Performance: Follow up on the quality and performance of selected products post-launch, ensuring they meet safety and efficacy standards, and address any issues that arise.
- Continuous Improvement: Drive continuous improvement initiatives to enhance product quality and process efficiency in the design and development phases.
- Coordinates customer escalations and non conformity to ensure a quick result and drive the CAPA process. Required competencies:
- Education: Bachelor degree or above in Engineering, Life Sciences, or a related field.
- Experience: Minimum of 5 years of experience in QA within the medical device industry, with at least 2 years focused on design and development.
- Profound understanding of QMS, ISO requirements (ISO13485, ISO14971, IEC62304, IEC62366,...) and regulatory to maintain business quality certifications.
- Excellent verbal and written communication skills, listening skills in both Chinese and English
- Solution directed and E2E continuous improvement attitude.
- Sound judgment and high level of integrity and ethics
- Excellent leadership and organizational skills; demonstrated ability to motivate others, work as a team and take ownership where required.
- Analytical, investigative and decision-making skills
- Ability to deal with and manage a diverse and demanding workload
- Technical, analytical, investigative and decision-making skills
- Able to cope with stressful situations, set priorities and be flexibl