QA Engineer II — Medical Device Quality & Compliance

NCSL International

South Carolina

On-site

USD 65,000 - 90,000

Full time

14 days+

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Benefits offered by this job

Medical, Dental and Vision Insurance
Company-Provided Life Insurance
Voluntary Life Insurance
Flexible Spending Account (FSA)
Matching 401(k) Retirement Plan
Annual Bonus

Job summary

Arthrex, Inc. in Pendleton, SC, is seeking a Quality Assurance Engineer II to support the Quality Manager across the life-cycle development of Class I–III medical devices. You will participate in design controls, risk management, CAPA, supplier quality, and process validations, while ensuring compliance with quality standards.

The role emphasizes cross-functional collaboration, data-driven problem solving, and continuous improvement to help deliver safe and effective medical devices.

Qualifications

  • Bachelor's degree in Engineering or Engineering Technology required.
  • 2 years experience in Quality Control/Quality Assurance in a Medical Device Company preferred.

Responsibilities

  • Support Quality Manager with life-cycle quality activities for Class I-III medical devices.
  • Review design drawings for tolerance, inspectability, and quality issues.
  • Lead or assist in design controls, risk management (PFMEA) and CAPA actions.
  • Conduct internal/external quality audits as directed.
  • Lead Nonconformance investigations and issuance of corrective actions.

Skills

Quality Assurance
Design Controls
GD&T
DOE
PFMEA
CAPA
Gage R&R
Statistical Analysis

Education

Bachelor's degree in Engineering or Engineering Technology

Tools

MiniTab
SAP
Pilgrim QMS
Excel

Job description

Arthrex, Inc. in Pendleton, SC, is seeking a Quality Assurance Engineer II to support the Quality Manager across the life-cycle development of Class I–III medical devices. You will participate in design controls, risk management, CAPA, supplier quality, and process validations, while ensuring compliance with quality standards.

The role emphasizes cross-functional collaboration, data-driven problem solving, and continuous improvement to help deliver safe and effective medical devices.

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