QA Engineer II: Medical Device Quality & Lifecycle

RiseMe; Pendleton (SC); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Life insurance

401(k) plan

Annual bonus

Job summary

Arthrex, Inc. in Pendleton, SC is seeking a Quality Assurance Engineer II to support lifecycle development of Class I-III medical devices. You will assist with design reviews, supplier quality, risk assessments, CAPAs, and QC inspections.

Requires a Bachelor's in Engineering, 2+ years in medical device QA/QC, and familiarity with Design Controls, PFMEA, DOE, and SPC. Onsite role with extensive cross-functional collaboration and growth opportunities.

Qualifications

• Bachelor's degree in Engineering or Engineering Technology.
• Minimum 2 years of QA/QC experience in medical devices.
• Experience with Design Controls, risk assessments, and DOE.
• Knowledge of SPC and problem-solving tools.
• Strong communication with technical and non-technical staff.

Responsibilities

• Support Quality Manager across lifecycle development of medical devices.
• Review designs for tolerance and inspect-ability, and coordinate supplier quality.
• Lead or participate in risk management, PFMEAs and CAPAs.
• Conduct internal/external audits and support NCRs and CAPA investigations.
• Develop inspection plans and metrology methods, and perform DOE studies.

Skills

Quality Assurance

Design Controls

FMEA

DOE

Statistical Analysis

Process Improvement

Risk Assessments

QA Documentation

Communication

Education

Bachelor's degree in Engineering or Engineering Technology

Tools

Minitab

Excel

SAP

Pilgrim QMS

Gage R&R tools

Job description

Arthrex, Inc. in Pendleton, SC is seeking a Quality Assurance Engineer II to support lifecycle development of Class I-III medical devices. You will assist with design reviews, supplier quality, risk assessments, CAPAs, and QC inspections.

Requires a Bachelor's in Engineering, 2+ years in medical device QA/QC, and familiarity with Design Controls, PFMEA, DOE, and SPC. Onsite role with extensive cross-functional collaboration and growth opportunities.