PR/159931 | QAQC Manager

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.