Quality Assurance Engineer II - Medical Devices

NCSL International; South Carolina; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Annual Bonus

Matching 401(k) Retirement Plan

Free Onsite Clinics

Paid Time Off

Job summary

Arthrex, Inc. in Pendleton, SC is seeking an Engineer II for Quality Assurance to support lifecycle development of medical devices. You will work with cross-functional teams to ensure design and process quality, run audits, and lead CAPA actions.

The role requires a Bachelor's in Engineering and 2 years in QA/QC, with strong knowledge of design controls, GD&T, and process validation. Onsite manufacturing campus with competitive benefits.

Qualifications

• Bachelor's degree in Engineering required.
• Minimum 2 years in Quality Control/QA roles.
• Experience in medical devices preferred.

Responsibilities

• Review design drawings for tolerance and quality.
• Collaborate with suppliers to improve quality and validate processes.
• Assist in training QC inspectors on techniques and equipment.
• Participate in internal and external quality audits.
• Lead or support FMEA and risk assessments.
• Execute IQ/OQ/PQ validations and CAPA investigations.
• Manage NCRs; trend nonconformances and drive actions.
• Support environmental monitoring and continuous improvement.

Skills

QA/Quality Assurance

Statistical analysis

Process improvement

Design Controls

GD&T

Communication

Project management

Education

Bachelor's degree in Engineering

Tools

Excel

Word

Minitab

SAP

Pilgrim QMS

Job description

Arthrex, Inc. in Pendleton, SC is seeking an Engineer II for Quality Assurance to support lifecycle development of medical devices. You will work with cross-functional teams to ensure design and process quality, run audits, and lead CAPA actions.

The role requires a Bachelor's in Engineering and 2 years in QA/QC, with strong knowledge of design controls, GD&T, and process validation. Onsite manufacturing campus with competitive benefits.