Sustaining Quality Engineer II – Medical Devices

CONMED; Memphis (TN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation

Excellent healthcare coverage

401K with company match

Employee Stock Purchase Plan

Tuition assistance

Job summary

CONMED is seeking a Sustaining Quality Engineer to support quality engineering activities across the product life cycle. This on-site Memphis, TN role focuses on ensuring ISO, FDA QSR, and EU MDR compliance and leading quality initiatives with cross-functional teams.

The role requires design controls, risk management, and capability in data analysis, with responsibilities spanning design reviews, CAPAs, and sustaining activities including complaint handling and audit support.

Qualifications

• BS in Engineering with 2+ years in medical device quality engineering or MS with 1+ year experience.
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971, EU MDR and related regulations.
• Experience reviewing design verification/validation protocols and risk management.
• Professional certifications such as CQE/CQA/CMQ/OE are desirable.

Responsibilities

• Supports risk management activities focused on clinician and patient safety.
• Reviews and approves design documents, verifications, and validations.
• Leads investigations for quality issues and coordinates CAPAs.
• Supports internal/external audits and data analysis for trend reporting.

Skills

Quality engineering

Regulatory knowledge

Analytical thinking

Communication

Problem solving

Documentation

Education

B.S. in Engineering (Electrical/Mechanical/Biomedical)

MS in Engineering

Tools

CQE

CQA

CMQ/OE

Lead Auditor

Design for Six Sigma

Job description

CONMED is seeking a Sustaining Quality Engineer to support quality engineering activities across the product life cycle. This on-site Memphis, TN role focuses on ensuring ISO, FDA QSR, and EU MDR compliance and leading quality initiatives with cross-functional teams.

The role requires design controls, risk management, and capability in data analysis, with responsibilities spanning design reviews, CAPAs, and sustaining activities including complaint handling and audit support.