Engineer Tech - QA - Night Shift - SC

Arthrex GmbH; Pendleton (SC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Matching 401(k) Retirement Plan

Annual Bonus

Tuition Reimbursement Program

Free Onsite Medical Clinics

Free Onsite Lunch

Paid Time Off

Job summary

Arthrex, Inc. is a global medical device company and a leader in orthopedics located in Pendleton, SC. The QA Engineer Tech will support Engineering in lifecycle development of medical devices, including new product development and maintenance of released products.

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

Qualifications

• 2+ years post-graduation work experience with a High School diploma or GED.
• 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 CAPA investigations.
• Facilitate NCRs material disposition plans, evaluations, and action plans.
• Perform routine Nonconformance and process trending and lead Quality review meetings.
• Investigate post-market manufacturing quality issues incl. complaint investigations and CAPA.
• Initiate and coordinate risk assessment activities.
• Support or lead Continuous Improvement projects.
• Review drawings for inspect-ability, manufacturability, and quality; create inspection plans.
• Support Metrology with inspection methods and gages; train inspectors.
• Support Engineering Change Management process.
• Support or lead First Article Inspection process and review FAI reports.
• Perform DOE and Engineering Studies.
• Support or lead equipment/process validation (IQ, OQ, PQ).
• Metrology with Gage R&R studies.
• Work with suppliers to improve quality; assist supplier RCA.
• Participate in internal and external quality audits.
• Support Risk Management via pFMEA and risk assessments.
• Other duties as assigned.

Skills

Root Cause Analysis

CAPA investigations

NCR handling

Risk assessment

Continuous Improvement

Inspection plans

Metrology

First Article Inspection

DOE

IQ/OQ/PQ

Effective communication

Education

High School diploma or GED

AS or some college

Medical device experience preferred

Tools

MS Office

NCR/CAPA software

SAP

Job description

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.

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 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.

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.

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.

• 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 Time Off
• 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.