Our client is a Japanese medical device manufacturing company specializing in the cardiovascular, neurovascular, and gastrointestinal fields. Be a part of their growing team and join their mission to provide cutting-edge technology that not only facilitates a minimally invasive treatment for patients but also addresses the everyday challenges faced in medical practice.
Job Responsibilities
Continuously improve QMS while ensuring ISO, customer requirements, and other regulations are met by conducting analysis and implementing CAPA.
Manage QC scope covering Final & Incoming Inspection, Return Product, and Packing.
Plan yearly Internal Audit, ISO audits, and Management Review.
Ensure complaints from Customers are monitored and handled accordingly.
Ensure issues related to Suppliers are addressed and reported accordingly.
Promote awareness of environmental control activities and the impact on product cleanliness.
Ensure QAQC personnel are properly trained and possess the required skills and qualifications.
Job Requirements
Min Degree in Engineering or other relevant field.
Min 7-10 years working in Medical Manufacturing industry.
Experience in project management and leading team towards project succession.
Experience handling product certification for MDR and FDA.
Meticulous and strong attention to detail, with strong knowledge in QA, QC, and QMS.