Engineer Tech - QA - SC

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing Inc. is actively searching for a Quality Assurance Engineer Tech for the Pendleton, SC location.  Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™

This is a Modified Weekend Shift position: Fri - Mon; 6:00 a.m. - 4:30 p.m.

Main Objective:

Responsible for supporting the Engineering department by assisting engineers with the lifecycle development of medical devices, including new product development and maintenance of released products.

Essential Duties and Responsibilities:

• Complete Root Cause Analysis Investigations and assist or lead (Sr. & Principal) Corrective/Preventive Action Plans (CAPA’s) investigations.
• Facilitate completion of manufacturing and supplier related Nonconformances (NCR’s) as assigned: material disposition plans, evaluations, and action plans.
• Perform routine Nonconformance and process trending and lead periodic Quality review meetings with the management team as needed.
• Investigate post market related manufacturing quality issues including complaint investigations, complaint trending, and initiating corrective and preventative actions as required.
• Initiate and coordinate risk assessment activities in accordance with Quality System requirements.
• Support, initiate or lead (Sr. & Principal) Continuous Improvement projects.
• Responsible for reviewing drawings for inspect-ability, manufacturability, and quality of design issues and subsequent creation and review of inspection plans for manufacturing, receiving inspection.
• Support Metrology with design and development of inspection methods and gages and assist in the training of QC Inspectors on inspection techniques and the use of new equipment.
• Support the AMI Engineering Change Management process by performing tasks as assigned.
• Support or Lead (Sr. & Principal) the internal manufacturing First Article Inspection process, review First Article Inspection Reports and samples (internal and/or supplier).
• Perform Engineering Studies and Design of Experiments (DOE) as needed.
• Support or Lead (Sr. & Principal) equipment or process validation (IQ, OQ, PQ).
• Support or Lead (Sr. & Principal) Metrology with Measurement System Analysis (Gage R&R) studies.
• Work with suppliers to improve quality, and assist, where necessary, supplier RCA and improvement initiatives.
• Participate in Internal and External quality audits as directed by the Quality Assurance Manager.
• Support Risk Management by leading or participating in cross-functional team pFMEA’s and Risk Assessments as required.
• Other duties as assigned.

Education and Experience:

• 2 Years of post-graduation work experience with a High School diploma or GED equivalent.
• AS or some college preferred.
• Experience in medical device or manufacturing preferred.
• Experience with engineering specification documents and Quality standards preferred.

Additional Duties & Responsibilities:

• Proficiency in generating inspection plans.
• Proficiency in generating training methods on inspection best practices.
• Support development of gauging, test methods.
• Knowledge of standards, design, manufacturing, and processes.
• Ability to understand engineering specifications, drawings, and manufacturing processes required.
• Knowledge and understanding NCR process and associated phases from initiation to closure.
• Ability to communicate effectively with technical and non-technical staff.
• Knowledge of MS Office, NCR/CAPA software and SAP.

Reasoning Ability:

Ability to define problems, collects data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

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:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.  Ability to verbally communicate ideas and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures.

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 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 Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• 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.