Engineer Sr. I QA Supplier

Arthrex - Naples, FL

Full-time - Mid Level

Naples, FL

Miscellaneous Manufacturing

About the position

The Engineer Sr. I, QA Supplier Quality at Arthrex, Inc. is responsible for managing and maintaining the supplier base to ensure that products and processes meet specifications. This role focuses on improving supplier product quality performance and developing adequate receiving inspection plans. The position involves collaboration with suppliers to enhance product and process quality, conducting audits, and ensuring compliance with quality management systems.

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 suppliers in writing and executing protocols and conducting process validations per internal requirements.
• Conduct supplier qualifications, including audits and closure of audit findings.
• Gather and review supplier Maintenance Repair or Operating (MRO) material lists to mitigate product risk.
• Compile and report on supplier performance metrics and statistics.
• Evaluate and adjust inspection plans based on supplier performance and controls.
• Initiate and assist suppliers with Corrective and Preventive Actions and ensure closure of actions.
• Train 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 in conjunction with suppliers.
• 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 lead technical discussions with a focus on cross-functional buy-in and results.

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)