Quality Specialist - ACT

Arthrex, Inc., a global medical device company and leader in new product development and medical education in orthopedics, is searching for a Quality Specialist for our Santa Barbara, CA facility. The role will support the Quality Department to maintain and improve the Arthrex Global Quality Management System (QMS) in compliance with FDA QSR, ISO 13485, MDSAP, and other applicable regulatory requirements.

The Quality Specialist will provide focused support for Quality areas including Nonconformance Records (NCRs), Corrective Action Preventative Action (CAPA), Deviations, Complaints, Device History Record (DHR) review, and Inspection Plans, and may offer backup support for other Quality Systems areas beyond primary responsibilities. The job requires supporting staff members in prioritizing work, communicating, training, process improvement, employee relations, and problem‑solving.

• 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.

• NCR / CAPA / Deviation management activities:
  Initiate nonconformances, deviations, and CAPAs as requested or identified in 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 complaint management system.
• May 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.

• Perform reviews of DHRs, product labels, and calibration orders for compliance and Good Documentation Practices (GDP).
• Communicate opportunities for improvement and report nonconformances to relevant stakeholders.
• Verify document content aligns with DMS, ERP/MRP and PLM Systems information.
• Perform administrative tasks including record scanning and filing.
• Higher level roles may serve as system SMEs, creating and providing guidance for quality documentation such as Manufacturing Rework Instructions (MRIs), Work Instructions (WIs) and Failure Mode Events Analysis (FMEA).

• Translation of engineering drawings into inspection plans using ERP/MRP and PLM Systems.
• Manage and communicate changes to inspection plans.
• Coordinate processing of incoming material: assign inspection plans, gather samples, ensure batch traceability and communicate nonconformances as needed.

• High school diploma or equivalent required.
• Post‑high school degrees or certifications are a plus.
• 2 years of working directly with customers to resolve concerns, problems, and questions.
• 1 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.