Quality Specialist - Complaint Management

Arthrex; Santa Barbara (CA); On-site; USD 3,663,038 - 4,831,243; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

Company-Provided Life Insurance

Annual Bonus

Tuition Reimbursement Program

Flexible Spending Account (FSA)

Matching 401(k) Retirement Plan

Paid Parental Leave

Paid Time Off

Voluntary Life Insurance

Job summary

Arthrex, Inc. in Santa Barbara, CA is seeking a Quality Specialist to support the Quality Department in maintaining the Arthrex Global QMS in FDA QSR, ISO 13485, MDSAP compliance.

You will handle NCRs, CAPAs, deviations, complaints, DHR review, and inspection plans while prioritizing training, process improvement, and problem solving. The role focuses on ensuring regulatory compliance with a collaborative, fast-paced team, with opportunities to contribute across quality systems and support

Qualifications

• 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.

Responsibilities

• 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.

Skills

Customer-facing experience

Quality control

Problem solving

Data entry

Education

High school diploma or equivalent

Post-high school degrees or certifications

Tools

Microsoft Office

Microsoft Excel

Job description

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

Essential Duties and Responsibilities

• 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.

Quality-Specific Tasks May Include

• 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.

Complaint Management Activities May Include

• 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.

Education and Experience

• 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 and Skill Requirements

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

Machine, Tools, and Equipment Skills

Microsoft Office, Microsoft Excel, PCs and office equipment.

Reasoning Ability

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

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

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.

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 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.

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 essential functions. The area where this job is performed 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 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 On‑site Lunch
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Paid Sick Leave
• Volunteer PTO
• Employee Assistance Program (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.