Senior Quality Engineer – Post‑Market & Regulatory

Avanos Medical; Norcross (GA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Total Rewards

401(k) match

Onsite gym

Onsite cafeteria

Job summary

Avanos Medical is seeking a Sr Quality Engineer to lead post-market surveillance activities, assess product performance, and drive regulatory compliance across global markets. The role involves preparing PMSR/PSUR, performing investigations with root cause analysis, and coordinating recalls with Quality, Regulatory, and Clinical teams.

You will collaborate with Regulatory Affairs and cross-functional partners to ensure alignment with risk management and technical files, while tracking timelines

Qualifications

• BS in Engineering, Science or related field with 7+ years in medical devices QA/R&D.
• CQE or Six Sigma certification desirable.
• Experience with FDA QMSR, MDR, ISO 13485, MDSAP and regulatory submissions.

Responsibilities

• Prepare PMSR/PSUR per EU MDR and applicable regulations.
• Investigate complaints: RCA, risk assessment, reportability decisions.
• Coordinate recalls/field actions with cross-functional teams.
• Support audits from Notified Bodies, FDA, ISO.
• Maintain documentation in quality systems and risk files.

Skills

Regulatory knowledge

Technical writing

Cross-functional coordination

Root cause analysis

Problem solving

Leadership

Communication

Education

B.S. in Engineering

Tools

Minitab

SAP

EtQ

Six Sigma

Document Control software

Job description

Avanos Medical is seeking a Sr Quality Engineer to lead post-market surveillance activities, assess product performance, and drive regulatory compliance across global markets. The role involves preparing PMSR/PSUR, performing investigations with root cause analysis, and coordinating recalls with Quality, Regulatory, and Clinical teams.

You will collaborate with Regulatory Affairs and cross-functional partners to ensure alignment with risk management and technical files, while tracking timelines