Engineer II QA Supplier Quality

Requisition ID:          66513 Title: Engineer II QA Supplier Quality Salary Range: Salary Minimum: $92,400 Salary Maximum:  $136,500

 

 

 

 

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™. 

 

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.
• 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%

 

Education/Experience:

• Bachelor's degree in Engineering required
• 2+ years relevant experience in a regulated industry

 

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.

 

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds.

 

Vision Requirements:

Visual acuity necessary to do the job safely and effectively.

 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation environment.  The noise level in the work environment is usually moderate.

 

 

 

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life In