Engineer Tech I -QA

Requisition ID : 63523 Title : Engineer Tech I -QA Division : Arthrex Manufacturing Inc (US02) Location : AMISC-B (US31)

Arthrex is a global medical device company and leader in orthopedics medical education. Arthrex is actively searching for a Engineer Tech I - QA. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

Schedule : M,W,F 7 : 30am-4 : 00pm

Essential Duties and Responsibilities :

• Complete Root Cause Analysis Investigations and assist or lead (Sr. & Principal) Corrective / Preventive Action Plans (CAPAs) investigations.
• Facilitate completion of manufacturing and supplier related Nonconformances (NCRs) 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 pFMEAs and Risk Assessments as required.
• Other duties as assigned.

Education and Experience :

Knowledge and Skill Requirements / Specialized Courses and / or Training :

Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.

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.

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

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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