Quality Specialist - Complaint Management

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are seeking a Quality Specialist at our Santa Barbara, CA facility to support the Quality Department in maintaining and enhancing the Arthrex Global Quality Management System (QMS) in compliance with FDA QSR, ISO 13485, MDSAP, and other regulatory requirements. The role focuses on areas such as Nonconformance Records (NCRs), Corrective Action Preventative Action (CAPA), Deviations, Complaints, Device History Record (DHR) review, and Inspection Plans, with potential backup roles across other Quality Systems areas.

The employee will ensure plan goals are achieved through prioritizing work, communication, training, process improvement, employee relations, and problem-solving.

Location: Santa Barbara, CA
ER Bonus: $1,500.00
Salary Range: $26.29 – $35.07

• Organize and coordinate Quality projects to ensure Arthrex QMS compliance.
• Guide and train QMS software users on regulatory and compliance requirements.
• Assist with regulatory compliance and medical device reporting.
• Support business/process owners in developing, revising, and reviewing QMS documents.
• Perform Quality data trending to meet requirements and management goals.
• Assist with Internal and External Audits, including preparation, documentation requests, and support.
• Record accurate and consistent information in a high-volume work environment.
• Maintain accurate files through administrative tasks such as scanning and archiving.

• Initiate nonconformances, deviations, and CAPAs as requested or identified during QC inspection.
• Communicate nonconformance creation and status to relevant internal and external team members.
• Assist with containment actions for nonconforming product, including ERP/MRP and PLM System transactions.
• Verify NCR, Deviation, and CAPA information; support disposition planning and evaluation tasks; perform final review and closure of NCRs.

• Review investigation results for accuracy.
• Record investigation findings into the complaint management system.
• Review relevant documents such as operating room reports, bills of lading, DHRs, and customer communications to extract information relevant to investigation.
• Report findings to internal staff, as required.
• Manage, contain, and retain devices associated with reportable complaints.

• High school diploma or equivalent required.
• Post‑high school degrees or certifications are a plus.
• At least 2 years of direct customer-facing experience resolving concerns, problems, and questions.
• One year as a Quality Control Inspector, Technician, or experience in the medical field is useful.

Knowledge of products and skills to maintain a positive approach to negative issues. High-level computer data entry skills.

Microsoft Office, Microsoft Excel, PCs and office equipment.

Ability to define problems, collect data, establish facts, and draw valid conclusions.

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

Excellent written and verbal skills, and the ability to record information accurately are required for this job. Communication skills are key to being effective in this role.

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 essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to 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 10 pounds.

Visual acuity necessary to do the job safely and effectively.

The work environment…