Tainan City, TW, TWN
1 day ago
Medical Device Quality Engineer
3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: Assumes responsibility for initiating and performing defined quality activities leading to new or improved processes or systems on a program level. Usually reports to a quality supervisor or senior technical individual. 1. Initiates and completes technical activities leading to new or improved products, processes or systems that have a significant impact at a program level. 2. Establishes and cultivates a network of resources (laboratory, manufacturing, engineering, sales, and marketing) to facilitate completion of assignments. 3. Participates in project planning. Assists in establishing project objectives and priorities. Maintains an awareness of quality improvement and product opportunities and is productive in suggesting and testing ideas. Conducts and leads inter-laboratory test method studies. Plans and leads quality system and process audits. 4. Documents results, observations and conclusions in technical notebooks (or approved electronic files) and prepares reports to communicate results to appropriate personnel. May occasionally train, counsel, and guide the technical and administrative work of others. Demonstrated ability to lead medium-sized teams is required. May lead projects over an extended period of time. 5. Technicians manufacturing IVD medical devices shall acquire at least one of the following qualifications: 5-1. A person graduated and obtained a diploma from biomedical engineering, medical laboratory science or relevant departments, graduate schools or degree courses at the domestic public or private university, or the foreign university which complies with the “Regulations Governing the Assessment and Recognition of Foreign Academic Records by Institutions of Higher Education” and recognized by the Ministry of Education. The person shall also engage in medical device manufacturing works in medical device manufacturer(s) for at least one year. 5-2. A person graduated and obtained a diploma from science, engineering, medicine, agriculture or relevant departments, graduate schools or degree courses at the domestic public or private university, or the foreign university which complies with the “Regulations Governing the Assessment and Recognition of Foreign Academic Records by Institutions of Higher Education” and recognized by the Ministry of Education. The person shall also engage in medical device manufacturing works in medical device manufacturer(s) for at least three years. 6. Experience in the following is preferred: 6-1. Full-time on-site supervision of the medical device manufacturing process. 6-2. Management of medical device quality system documentation. 6-3. Management of adverse events related to medical devices. 6-4. Management of safety supervision matters for medical devices. 5. The medical device training course should consist of at least eight hours of education and training, and it is preferable to log into the "Digital Learning Network for Medical Devices and Cosmetics of the Food and Drug Administration of the Ministry of Health and Welfare" to complete courses in five categories: "Laws and Regulations Related to Medical Devices in Our Country", "Quality Management System for Medical Device Product Manufacturing", "Preparation and Management of Inspection and Registration Document Data", "Practical Submission for Inspection and Registration", and "Post-Marketing Management of Medical Device Products". Learn more about 3M’s creative solutions to the world’s problems at www.3M.com or on Instagram, Facebook, and LinkedIn @3M. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. 3M Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at 3M are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here (http://multimedia.3m.com/mws/media/1274940O/3m-jobs-country-data-privacy-statements-external.pdf) , select the country where you are applying for employment, and review. Before submitting your application, you will be asked to confirm your agreement with the terms.
Confirm your E-mail: Send Email