Quality Compliance Specialist – CAPA, NCRs & QMS

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. 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