Engineer I - Supplier Quality

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Join our talented team focused on Helping Surgeons Treat Their Patients Better™.

About the role

We are actively searching for an Engineer I, Supplier Quality, who is responsible for managing supplier activities related to the specific site(s) to which the employee is stationed, in addition to local and global Arthrex QMS requirements.

Responsibilities

• Understand and apply external regulatory and internal QMS requirements for Supplier Quality.
• Accountable for supplier-caused nonconformances, including nonconformance coordination, containment of nonconforming material, evaluation of nonconforming material, and execution of action plans.
• Drive supplier Corrective and Preventative Actions (CAPAs) and/or own supplier-facing action plans, including assisting suppliers with CAPAs.
• Responsible for assisting in complaint investigations related to product quality from suppliers.
• Provide pertinent information as requested by auditors to assist with external audits of Arthrex or suppliers.
• Participate in Supplier, part, or inspection qualification.
• Hold workshops, regular cadence meetings, and other events to drive alignment and improvement with suppliers.
• Work with suppliers to ensure that established requirements are being facilitated and met at the supplier’s location.
• Gather and present data to leadership monthly for team/site performance.
• Report progress and status of assigned projects on a timely basis.

Requirements

• Bachelor’s degree in Engineering required.
• Experience in a regulated industry preferred.
• Knowledge of FDA and ISO guidelines for the development of medical devices preferred.
• Basic manufacturing and inspection process knowledge preferred.

Skills

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret a variety of technical instructions in mathematical or diagram form and deal with abstract and concrete variables.
• Ability to comprehend and apply mathematical principles to the degree required by job responsibilities.
• Strong verbal and written communication skills, including the ability to effectively convey ideas and issues to team members and management.
• Ability to quickly learn and apply knowledge.

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)