Medical Device Design Quality Engineer II — On-Site Memphis

FHLB Des Moines; Memphis (TN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Competitive compensation

Excellent healthcare including medical

401K with company match

Tuition assistance

Employee referral program incentives

Job summary

CONMED Corporation seeks a Design Quality Engineer II to support quality engineering activities across the new product life cycle, from concept to commercialization, and sustaining activities. The role serves as the quality engineering contact and key resource for ISO, EU MDR, and FDA QSR compliance in a cross-functional team.

The on-site position in Memphis, TN requires collaborating with multiple functions to ensure product design meets customer, regulatory, and standards requirements while

Qualifications

• Requires a B.S. in Engineering and 2+ years medical device experience (or an M.S. with 1+ year).
• Familiarity with Quality Systems Regulations and ISO quality requirements; knowledge of 21 CFR 820, ISO 13485, ISO 14971, EU MDR.
• Professional certifications (CQE, CQA, CMQ/OE) are desirable.
• Design controls knowledge and ability to apply risk management.

Responsibilities

• Support product development with required quality deliverables across the life cycle.
• Review and approve design documentation to ensure regulatory compliance.
• Lead risk management activities focusing on clinician and patient safety.
• Investigate quality issues and drive corrective actions across functions.
• Support internal and external audits and surveillance activities.

Skills

Quality engineering

Regulatory compliance

Risk management

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

CQE

CQA

CMQ/OE

Job description

CONMED Corporation seeks a Design Quality Engineer II to support quality engineering activities across the new product life cycle, from concept to commercialization, and sustaining activities. The role serves as the quality engineering contact and key resource for ISO, EU MDR, and FDA QSR compliance in a cross-functional team.

The on-site position in Memphis, TN requires collaborating with multiple functions to ensure product design meets customer, regulatory, and standards requirements while