Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. 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 requirement.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Understand and apply external regulatory and internal QMS requirements for Supplier Quality.
• Accountable for supplier-caused nonconformances, including, but not limited to, nonconformance coordination, containment of nonconforming material, evaluation of nonconforming material, and execution of action plans.
• Drive supplier Corrective and Preventative Actions (CAPAs) and/or owns 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.
• Works 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.
• This Job description represents Supplier Quality Engineering roles in different capacities and at different levels. Reference table below for position specific details.
• Knowledge of FDA and ISO guidelines for the development of medical devices preferred.
• Basic manufacturing and inspection process knowledge preferred.
• Shows ability to quickly learn and apply knowledge

Education and Experience:

• Bachelors degree in Engineering required
• Experience in a regulated industry preferred

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.  Ability to verbally communicate ideas and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures.

Arthrex 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)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.