Quality Engineer II – Medical Device Quality & Impact

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

Benefits offered by this job

Medical insurance

Dental and Vision insurance

Company-provided Life Insurance

401(k) Retirement Plan

Annual Bonus

Onsite Medical Clinic

Onsite Lunch

Tuition Reimbursement

Paid Time Off

Job summary

Arthrex, Inc. in Pendleton, SC, is seeking a Quality Engineer II to support lifecycle quality for Class I–III medical devices. The role requires a BS in Engineering and 2+ years in quality or QA roles, with emphasis on design controls and risk management.

You will collaborate across functions to ensure compliant product development and manufacturing processes. Responsibilities include design reviews, supplier quality, audits, CAPAs, PFMEAs, and cross-functional problem solving.

Qualifications

• 2+ years in Quality Control/Quality Assurance in a medical device setting.
• Bachelor of Science in Engineering or higher is required.
• Experience with FDA/ISO13485 and risk management is preferred.
• Strong problem-solving and cross-functional collaboration skills.

Responsibilities

• Support Quality Manager with lifecycle quality for Class I–III devices.
• Review designs and supplier quality; participate in validations.
• Train QC inspectors and contribute to internal/external audits.
• Lead RCAs, CAPAs, PFMEAs, and risk assessments as needed.
• Execute NC/NCRs, nonconformance trending, and quality reviews.

Skills

Quality Assurance

Quality Systems

Process Validation

Design Controls

GD&T

Risk Management

CAPA

DOE

Education

BS in Engineering

Biomedical/Electrical/Mechanical preferred

Tools

Excel

MiniTab

SAP

Windchill

IQVIA Smartsolve

Job description

Arthrex, Inc. in Pendleton, SC, is seeking a Quality Engineer II to support lifecycle quality for Class I–III medical devices. The role requires a BS in Engineering and 2+ years in quality or QA roles, with emphasis on design controls and risk management.

You will collaborate across functions to ensure compliant product development and manufacturing processes. Responsibilities include design reviews, supplier quality, audits, CAPAs, PFMEAs, and cross-functional problem solving.