Quality Assurance Engineer II - Medical Devices Impact

Arthrex; Pendleton (SC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Annual Bonus

Paid Time Off

Tuition Reimbursement

Job summary

Arthrex is hiring a Quality Assurance Engineer II at our Pendleton, SC site to support lifecycle QA for Class I-III medical devices. You will assist in design controls, risk assessments, and CAPA activities, while collaborating with manufacturing, suppliers, and R&D.

The role emphasizes data-driven problem solving, process validation, and continuous improvement. The ideal candidate has a technical degree and 2 years in QA/QC, with strong communication skills and familiarity with QMS tools such

Qualifications

• Bachelor's degree in engineering or engineering technology.
• 2 years of QA/QC experience in a medical device environment.
• Experience with design controls, GD&T, DOE, and process verification/validation.
• Knowledge of SPC and statistical tools.
• Familiarity with PFMEAs, control plans, and quality plans.
• Strong communication and cross-functional collaboration.
• Project management skills preferred.

Responsibilities

• Support Quality Manager with lifecycle quality activities for Class I-III medical devices.
• Review drawings for design quality and inspect-ability.
• Lead or participate in risk assessments and PFMEA.
• Support supplier quality and process validations.
• Lead or support NC investigations and CAPA actions.
• Assist in continuous improvement and validation activities.
• Provide technical guidance to inspectors and QC team.
• Contribute to internal/external quality audits.
• Maintain and improve QMS documentation and inspection processes.

Skills

Quality Assurance

Communication

Project Management

Problem Solving

Education

Bachelor's degree in Engineering or Engineering Technology

Tools

Minitab

Excel

SAP

Agile PLM

Pilgrim QMS

Job description

Arthrex is hiring a Quality Assurance Engineer II at our Pendleton, SC site to support lifecycle QA for Class I-III medical devices. You will assist in design controls, risk assessments, and CAPA activities, while collaborating with manufacturing, suppliers, and R&D.

The role emphasizes data-driven problem solving, process validation, and continuous improvement. The ideal candidate has a technical degree and 2 years in QA/QC, with strong communication skills and familiarity with QMS tools such