Quality Assurance Engineer II – Medical Devices

Arthrex GmbH; Pendleton (SC); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

401(k) Retirement Plan

Annual Bonus

Free Onsite Lunch

Tuition Reimbursement Program

Paid Time Off

Employee Assistance Program (EAP)

Job summary

Arthrex, Inc. is seeking a Quality Assurance Engineer II for our Pendleton, SC manufacturing location. You will support the Quality Manager in lifecycle development of Class I-III medical devices, including new product development and maintenance of released products.

Responsibilities include leading or supporting FAI inspections, CAPAs, risk assessments, supplier quality, audits, and continuous improvement initiatives. A BS in engineering with 2 years in medical device quality is required.

Qualifications

• Bachelor's degree in Engineering or Engineering Technology.
• 2 years experience in quality roles within medical devices.
• Experience with Design Controls, GD&T, and DOE.
• Knowledge of SPC and risk assessment tools.
• Strong communication across cross-functional teams.

Responsibilities

• Review design drawings for tolerance, inspect-ability and quality issues.
• Collaborate with suppliers to improve quality and assist in supplier validations.
• Train QC Inspectors on inspection techniques and new equipment.
• Lead or participate in internal/external quality audits.
• Support risk management, PFMEAs and risk assessments.
• Assist in AMI Engineering Change Management tasks.
• Lead/participate in First Article Inspection processes and related reports.
• Lead/Support equipment or process validation (IQ, OQ, PQ).
• Lead or support Metrology in inspection methods and gages.
• Create/Review inspection method work instructions.
• Lead/Support MSA (Gage R&R) studies.
• Create inspection plans for receiving and in-process inspection.
• Investigate complaints with the Reliability team.
• Close NCRs with disposition plans and CAPA actions.
• Perform QC trending and quality review meetings.
• Lead Continuous Improvement projects.
• Support Environmental Monitoring program.
• Complete Root Cause Analysis and CAPA actions.
• Conduct DOE studies as needed.
• Perform other duties.

Skills

Quality Assurance

Design Controls

GD&T

DOE

Process Validation

SPC

Lean Six Sigma

Kepner-Tregoe

5 Whys

Communication

Education

Bachelor's degree in Engineering or Engineering Technology

Tools

Excel

Minitab

SAP

Agile

Pilgrim QMS

Job description

Arthrex, Inc. is seeking a Quality Assurance Engineer II for our Pendleton, SC manufacturing location. You will support the Quality Manager in lifecycle development of Class I-III medical devices, including new product development and maintenance of released products.

Responsibilities include leading or supporting FAI inspections, CAPAs, risk assessments, supplier quality, audits, and continuous improvement initiatives. A BS in engineering with 2 years in medical device quality is required.