Engineer Tech - QA - Night Shift - SC

Summary

Arthrex, Inc. is a global medical device company focused on orthopedic product development and medical education. The Quality Assurance Engineering Technician supports engineers throughout the lifecycle development and maintenance of medical devices by conducting quality investigations, supporting validation and risk management activities, and contributing to continuous improvement and supplier quality initiatives.

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

Skills

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

Qualifications

Must Haves

• 2 Years of post-graduation work experience with a High School diploma or GED equivalent
• 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
• 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
• 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

Nice to Haves

• AS or some college preferred
• Experience in medical device or manufacturing preferred
• Experience with engineering specification documents and Quality standards preferred

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)