Arthrex - Naples, FL
posted 3 months ago
Arthrex, Inc. is a global leader in medical device development and education in orthopedics, and we are currently seeking an Engineer Sr. I, QA Supplier Quality. This role is pivotal in managing and maintaining our supplier base to ensure that both products and processes meet stringent specifications. The Engineer will work closely with suppliers to enhance product quality performance and establish effective receiving inspection plans. The successful candidate will join a talented team dedicated to the mission of Helping Surgeons Treat Their Patients Better™. In this position, the Engineer will be responsible for reviewing design drawings and processes with suppliers to ensure compliance and inspectability. The role involves collaborating with suppliers to improve product and process quality through various initiatives, including onsite workshops, development of Process Failure Mode Effects Analysis (PFMEAs), Control Plans, and conducting correlation studies and inspection plans. The Engineer will also engage with suppliers on process improvements, validations, and supplier-initiated change notifications to ensure that all processes meet internal and external specifications. Additionally, the Engineer will be tasked with supplier qualifications, which includes developing questionnaires, audit plans, and conducting supplier audits. The role requires gathering and reviewing supplier Maintenance Repair or Operating (MRO) material lists to mitigate product risk. The Engineer will compile and report on supplier performance metrics, evaluate inspection plans based on supplier performance, and assist suppliers with Corrective and Preventive Actions to ensure closure of audit findings. Training and assisting supplier quality personnel in inspection techniques and the use of new equipment will also be part of the responsibilities. The Engineer will assist in designing and developing methods and tooling for testing and inspection, ensuring that suppliers adhere to established requirements. Furthermore, the role involves writing and developing quality management system processes, work instructions, and forms in collaboration with suppliers and internal purchasing controls. The Engineer will also assist in complaint investigations related to product quality from suppliers. This position requires travel up to 50% of the time.