Engineer Tech - QA - Night Shift - SC

Arthrex•Pendleton, SC

36d•Onsite

About The Position

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 Night Shift position: Mon – Thu: 11:30 p.m. - 10:00 a.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.

Requirements

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

Nice To Haves

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

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.