What are the responsibilities and job description for the Quality Specialist position at Arthrex?
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 who i nvestigates nonconformances and/or customer complaints related to condition or use of medical products. The ability to prioritize work, communicate effectively, and problem solve are critical for this role. 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.
Serve as back-up for Device History Record review/product release
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.
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Nearest Major Market: Santa Barbara
Nearest Secondary Market: Santa Maria
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.
Serve as back-up for Device History Record review/product release
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.
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Nearest Major Market: Santa Barbara
Nearest Secondary Market: Santa Maria
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