QA Engineer II - Medical Device Quality & Compliance

Arthrex GmbH; South Carolina; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Annual Bonus

Onsite Medical Clinic

Onsite Lunch

Tuition Reimbursement

401(k) Matching

Paid Time Off

EAP

Job summary

Arthrex, Inc. is seeking an Engineer II for Quality Assurance on our Pendleton, SC campus.

You will support the Quality Manager in the lifecycle development and maintenance of Class I–III medical devices, working with cross-functional teams to ensure design quality and regulatory compliance. The role emphasizes design controls, PFMEAs, risk assessments, and process validation while coordinating audits and continuous improvement efforts.

Qualifications

• 2 years experience in a Quality Control or Quality Assurance position; medical device experience preferred.
• Technical knowledge in development methodologies including: Design Controls, GD&T, DOE, Process Verification and Validation.
• SPC (Statistical Process Control) knowledge.
• Experience with risk assessments, PFMEAs, control plans, and quality plans.
• Strong communication skills with technical and non-technical staff.

Responsibilities

• Review design drawings for tolerance, inspect-ability and quality of design issues.
• Work with suppliers to improve quality and assist in supplier process validations.
• Train QC Inspectors on inspection techniques and new equipment.
• Participate in internal and external quality audits as directed by QA Manager.
• Lead or support CAPA and nonconformance investigations and action plans.
• Lead or support environmental monitoring and DOE studies as needed.
• Create or review inspection method work instructions and test plans.
• Support Risk Management with cross-functional PFMEA and risk assessments.
• Perform routine nonconformance trending and quality reviews with management.

Skills

Quality Assurance

Design Controls

GD&T

DOE

Process Verification

Process Validation

SPC

Lean

Six Sigma

Problem Solving

Cross-functional Communication

Education

2 years experience in Quality Control/QA

Tools

Excel

Word

MiniTab

SAP

Pilgrim QMS

Agile/Design Lifecycle Software

Job description

Arthrex, Inc. is seeking an Engineer II for Quality Assurance on our Pendleton, SC campus.

You will support the Quality Manager in the lifecycle development and maintenance of Class I–III medical devices, working with cross-functional teams to ensure design quality and regulatory compliance. The role emphasizes design controls, PFMEAs, risk assessments, and process validation while coordinating audits and continuous improvement efforts.