Sustaining Quality Engineer II – Medical Devices

CONMED Corporation; Memphis (TN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Competitive pay

Healthcare coverage

Disability insurance

401K plan

Stock purchase plan

Tuition assistance

Job summary

CONMED Corporation seeks a Sustaining Quality Engineer to support quality activities from concept to commercialization and beyond in an on-site Memphis setting. You will be the quality engineering contact, ensuring ISO/QSR compliance and driving cross-functional initiatives to improve design, risk management, and manufacturing quality.

Responsibilities include reviewing design documentation, leading CAPA activities, and supporting audits while maintaining a strong focus on patient safety and

Qualifications

• BS in Engineering with 2+ years in medical device quality engineering, or MS with 1+ year experience.
• Knowledge of Quality System Regulations and ISO quality requirements.
• Familiarity with 21 CFR 820, ISO 13485, EU MDR.
• Experience reviewing design verification/validation protocols and reports.
• Ability to lead risk management activities focused on safety.

Responsibilities

• Support product development teams for required quality deliverables.
• Ensure product design meets regulatory requirements and customer needs.
• Review and approve design documentation for quality and manufacturability.
• Lead investigations and corrective/preventive actions across functions.
• Support sustaining activities including complaint handling and trend analysis.
• Coordinate internal and external quality audits and preparedness.

Skills

Quality systems

Regulatory compliance

Risk management

Design controls

Problem solving

Documentation

Cross-functional collaboration

Education

B.S. in Engineering

M.S. in Engineering

Tools

CAPA process

FMEA

Job description

CONMED Corporation seeks a Sustaining Quality Engineer to support quality activities from concept to commercialization and beyond in an on-site Memphis setting. You will be the quality engineering contact, ensuring ISO/QSR compliance and driving cross-functional initiatives to improve design, risk management, and manufacturing quality.

Responsibilities include reviewing design documentation, leading CAPA activities, and supporting audits while maintaining a strong focus on patient safety and