Title:
Quality Specialist - ACT
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™.
Essential Duties and 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.
Quality-specific tasks may include:
NCR / CAPA / Deviation management activities may include:
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.
Complaint management activities may include:
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.
Document management activities may include:
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).
Inspection Plan management activities may include:
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.
Education and Experience:
- 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 and Skill Requirements/Specialized Courses and/or Training:
Knowledge of products and skills to maintain a positive approach to negative issues. High-level computer data entry skills.
Machine, Tools, and/or Equipment Skills:
Microsoft Office, Microsoft Excel, PCs and office equipment.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Mathematical Skills
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills:
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.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit; use hands and fingers to handle or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.
Vision Requirements:
Visual acuity necessary to do the job safely and effectively.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate.
Arthrex 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)
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
