Quality Specialist I

Arthrex • Santa Barbara, CA

152d • $23 - $31

About The Position

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 Quality Specialist who 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 all other applicable regulatory requirements. The Quality Specialist role provides focused support for Quality areas, including Nonconformance Records (NCRs), Corrective Action Preventative Action (CAPA), Deviations, Complaints, Device History Record (DHR) review, and Inspection Plans. Additionally, the Quality Specialist may offer backup support for other Quality Systems areas beyond primary responsibilities. The individual ensures plan goals are achieved by supporting staff members in prioritizing work, communication, training, process improvement, employee relations, and problem-solving. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

Requirements

• High School diploma or equivalent required.
• Previous experience working in a regulated or manufacturing industry and in support of a Quality Management System is preferred.
• Knowledge of products and skills to maintain a positive approach to negative issues.
• High-level computer data entry skills.
• Excellent written and verbal skills and the ability to record information accurately.

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.
• 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 in complaint management.
• Record investigation findings into complaint management system.
• Perform reviews of DHRs, product labels, and calibration orders for compliance and Good Documentation Practices (GDP).
• Translate engineering drawings into inspection plans using ERP/MRP and PLM Systems.

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 Onsite Lunch
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Paid Sick Leave
• Volunteer PTO
• Employee Assistance Provider (EAP)

What This Job Offers

• Industry: Miscellaneous Manufacturing
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees