Quality Specialist

1 week ago

Santa Barbara, United States Arthrex España Full time
Requisition ID: 61876 Title: Quality Specialist Division: Arthrex California Inc (US03) Location: Santa Barbara, Ca Salary Range: Salary Minimum: $27.50 Salary Maximum: $37.50

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 investigate nonconformances and/or customer complaints related to the condition or use of medical products. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

Essential Duties And Responsibilities

  • Coordinate and lead assigned tasks supporting the complaint investigation process:
  • Coordinate the investigation by inspecting devices, preparing devices for engineering evaluations or following through with vendor evaluations.
  • Record detailed observations of products as received and confirm by evidence any non-conformances reported with the product.
  • May review operating room reports, bills of lading, device history records, communications with customers and other documentation to extract relevant investigation information.
  • Report back to customers or designated internal staff with findings in written or verbal format as requested.
  • Manage, assemble, maintain standard closing statements and own the closing tasks.
  • Coordinate and lead assigned tasks supporting the nonconformance (NC) process
  • Identify and initiate nonconformances and deviations as requested by Quality Engineers or as identified in QC Inspection
  • Assist with scoping and perform containment actions for nonconforming product, including material transactions in the ERP/MRP system and PLM System (SAP, Agile)
  • Verify Nonconformance Record (NCR) information and determine correct Team members
  • Communicate creation and status of nonconformances to applicable internal and external Team members
  • Support the Disposition Planning and Evaluation tasks with Team members
  • Perform final review and closure of NCR’s.
  • Assist in the creation and presentation of Quality Metrics.
  • Assist QA and Engineering functions with sampling and ad hoc (non-routine) inspection/testing requests to support engineering studies, validation, and environmental and process monitoring. May support standard inspection activities.
  • Assist with general regulatory compliance and medical device report submission activities.
  • Record accurate and consistent information in a high volume work area.
  • Maintain accurate and complete files by supporting archival activities such as scanning/archiving.
  • Individual productivity is consistent maintaining throughput and tasks assigned by the QA/QC Manager.
  • Priorities are aligned with Purchasing and Production requests and with QA/QC Mangers/Supervisors plan.
  • Assist in Quality Management System compliance tasks.

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. Intermediate level computer data entry skills.

Machine, Tools, And/or Equipment Skills

Microsoft Office, PCs and office equipment, inspection 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 a 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 the 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.

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