Quality Specialist - ACT

Arthrex

2d•$23 - $33•Onsite

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 a Quality Specialist for our Santa Barbara, CA facility. The Quality Specialist 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 growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

High school diploma or equivalent required
2 years of working directly with customers to resolve concerns, problems, and questions
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.
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Excellent written and verbal skills and the ability to record information accurately are required for this job.
Communication skills are the key to being effective in this job.

Nice To Haves

Post high school degrees or certifications are a plus
1 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.
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.
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 traceabilty and communicate nonconformances as needed.