Quality Specialist - Complaint Management

About the role

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 a Quality Specialist for our Santa Barbara, CA facility.

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.
• Aid in 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.
• May Include 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.
• May Include Complaint Management Activities: 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.

Qualifications

• 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.

Skills

• 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.

Education

• 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.

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
• Employee Assistance Provider (EAP)