QA Engineer II – Medical Devices, Quality & CAPA Lead

Arthrex; Pendleton (SC); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

FSA

Annual Bonus

Tuition Reimbursement

Parental Leave

Paid Time Off

Volunteer PTO

Job summary

Arthrex, Inc. is a global medical device company seeking an Engineer II for Quality Assurance on our Pendleton, SC campus. The role supports the Quality Manager in lifecycle development for Class I–III devices, including new product development and maintenance of released products.

Responsibilities include leading or supporting inspection methods, metrology, CAPA, risk assessments, audits, and continuous improvement projects to ensure product quality and compliance.

Qualifications

• Bachelor's degree in Engineering required.
• 2 years in Quality Control/Quality Assurance, medical device preferred.
• Strong knowledge of Design Controls, GD&T, DOE and process verification/validation.

Responsibilities

• Review design drawings for tolerance, inspect-ability and quality issues.
• Lead or participate in cross-functional PFMEA and risk assessments.
• Support internal/external quality audits and CAPA activities.
• Lead or support First Article Inspection and validation activities (IQ/OQ/PQ).
• Create or review inspection plans and metrology methods.
• Investigate complaints and lead NCRs and trending.

Skills

Quality Assurance

Design Controls

GD&T

DOE

Process Validation

Risk Management

Statistical Methods

Education

Bachelor's degree in Engineering

Tools

MINITAB

SAP

Pilgrim QMS

Job description

Arthrex, Inc. is a global medical device company seeking an Engineer II for Quality Assurance on our Pendleton, SC campus. The role supports the Quality Manager in lifecycle development for Class I–III devices, including new product development and maintenance of released products.

Responsibilities include leading or supporting inspection methods, metrology, CAPA, risk assessments, audits, and continuous improvement projects to ensure product quality and compliance.