Senior Quality Engineer

Job overview

The Senior Quality Engineer is an onsite role based in Alpharetta, GA. Compensation is not specified, and this position supports the Quality Assurance and Regulatory Compliance department. This role exists to monitor, analyze, and report on product performance and safety data for medical devices. The engineer ensures regulatory compliance by managing post-market surveillance, complaint investigations, and field actions.

What you'll do

• Prepare and maintain Post-Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR).
• Collaborate with Regulatory Affairs and Clinical teams.
• Support internal and external audits.
• Conduct investigations into product complaints including root cause analysis.
• Support field corrective actions and recalls.
• Document findings in compliance with SOPs.

What we're looking for

Skills & competencies

full-time

day shift

quality engineer

regulatory compliance

alpharetta ga

avanos medical

onsite

medical device

post-market surveillance

quality assurance

Work arrangement

• Weekend coverage required

Benefits & perks

• Total Rewards package, 401(k) match, benefits on day 1, free onsite gym, onsite cafeteria.

Why this role

Requires 7+ years of experience, onsite role, focus on EU MDR and FDA compliance.

About the employer

Avanos Medical is hiring for this role. Industry: Surgical and Medical Instrument Manufacturing. Sector: 33.