Engineer II QA Supplier Quality

Arthrex•Santa Barbara, CA

2d•$92,400 - $136,500•Onsite

About The Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer II QA Supplier Quality for our Santa Barbara facility. The SQE II 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. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

Bachelor's degree in Engineering required
2+ years relevant experience in a regulated industry
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.
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
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.

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.
Supplier nonconformances and CAPAs impacting assigned Arthrex site.
S&D activities related to select suppliers primarily supporting the assigned Arthrex site.
Drive inspection alignment and refinement
Support containment and product disposition
Assist with correlation studies and Gage R&Rs
Travel up to 20%