Engineer Sr. I QA Supplier

Arthrex - Naples, FL

Full-time - Mid Level

Naples, FL

Miscellaneous Manufacturing

About the position

Arthrex, Inc. is a global leader in medical device development and education, particularly in orthopedics. We are currently seeking an Engineer Sr. I, QA Supplier Quality to join our team in Naples, FL. This role is pivotal in managing and maintaining our supplier base to ensure that both products and processes meet stringent specifications. The Engineer Sr. I will work closely with suppliers to enhance product quality performance and develop effective receiving inspection plans. This position is integral to our mission of Helping Surgeons Treat Their Patients Better™. The Engineer Sr. I will be responsible for reviewing design drawings and processes with suppliers to ensure compliance and inspectability. This includes collaborating with suppliers to improve product and process quality through onsite workshops, developing Process Failure Mode Effects Analysis (PFMEAs) and Control Plans, and assisting with correlation studies and inspection plans. The role also involves engaging with supplier process improvements, process validations, and supplier-initiated change notifications to ensure that both internal and external processes meet specifications. In addition, the Engineer Sr. I will oversee supplier qualifications, which includes developing questionnaires, audit plans, and conducting supplier audits. The position 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 supplier quality personnel in inspection techniques and assisting in the design and development of testing methods and tooling are also key responsibilities. This role requires travel up to 50% of the time, reflecting the need for direct engagement with suppliers.

Responsibilities

• Review design drawings and processes with suppliers to ensure inspectability and compliance.
• Work with suppliers to improve product and process quality through onsite workshops and development of PFMEAs / Control Plans.
• Engage with supplier process improvements, process validations, and supplier-initiated change notifications.
• Assist in writing and executing protocols and conducting process validations per internal requirements.
• Conduct supplier qualifications using questionnaires, audit plans, and audits, and engage with suppliers to close audit findings.
• Gather and review supplier MRO material lists to mitigate product risk.
• Compile and report on supplier performance metrics and statistics.
• Evaluate and determine inspection plans based on supplier performance and controls.
• Initiate and assist suppliers with Corrective and Preventive Actions and ensure actions are closed.
• Train and assist supplier quality personnel in inspection techniques and new equipment usage.
• Assist in designing and developing methods and tooling for testing and inspection of articles.
• Ensure suppliers operate in accordance with established requirements.
• Write and develop quality management system processes, work instructions, and forms with suppliers and internal purchasing control requirements.
• Assist in complaint investigations related to product quality from suppliers.

Requirements

• Bachelor's degree in Engineering or Engineering Technology required.
• 5+ years of experience in a Quality Control or Quality Assurance position in a Medical Device Company required.
• Experience working within the guidelines of a Quality Management System.
• Knowledge of testing equipment, statistical methods, validation methods, problem solving, and control plans.

Nice-to-haves

• Proficiency in the use of PC and programs, particularly Excel, Word, PowerPoint, Visio, Minitab, Outlook, and SAP or similar ERP software.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret technical instructions in mathematical or diagram form.

Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)