Quality Assurance Engineer II - Medical Devices Impact

Arthrex GmbH; South Carolina; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

Flexible Spending Account (FSA)

Matching 401(k) Retirement Plan

Annual Bonus

Wellness Incentive Program

Free Onsite Medical Clinics

Free Onsite Lunch

Tuition Reimbursement Program

Job summary

Arthrex, Inc. in Pendleton, SC, is seeking a Quality Assurance Engineer II to support life cycle development of Class I–III medical devices. You will collaborate with the Quality Manager to ensure robust design controls, risk management, and supplier quality across manufacturing and development.

The role emphasizes PFMEA, CAPA, DOE, and continuous improvement, with cross-functional teamwork, audits, and data-driven quality activities in a dynamic medical device environment.

Qualifications

• Bachelor's degree in Engineering or Engineering Technology required.
• Minimum 2 years of QA/QC experience in a medical device company.
• Knowledge of Design Controls, PFMEA, CAPA and risk assessment tools.

Responsibilities

• Review design drawings for tolerance, inspect-ability and design quality.
• Lead or support PFMEAs and risk assessments across projects.
• Assist in internal/external quality audits and supplier quality.
• Lead NCRs, CAPA actions and root cause investigations.
• Develop and review inspection methods and Gage R&R studies.

Skills

Design Controls

GD&T

PFMEA

CAPA

DOE

Quality Metrics

Risk Assessment

Minitab

SAP

Education

Bachelor's degree in Engineering or Engineering Technology

Tools

Minitab

Pilgrim QMS

SAP

Excel

Job description

Arthrex, Inc. in Pendleton, SC, is seeking a Quality Assurance Engineer II to support life cycle development of Class I–III medical devices. You will collaborate with the Quality Manager to ensure robust design controls, risk management, and supplier quality across manufacturing and development.

The role emphasizes PFMEA, CAPA, DOE, and continuous improvement, with cross-functional teamwork, audits, and data-driven quality activities in a dynamic medical device environment.