Senior R&D Quality Engineer — Medical Devices

Regulatory Jobs; Versailles (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Regulatory Jobs seeks an experienced R&D Quality Engineer III to lead and enforce product development quality initiatives for medical devices. You will drive regulatory compliance, risk management, and documentation across the NPD lifecycle.

Key focus areas include leading FMEA processes, applying Six Sigma methods, and mentoring junior engineers while collaborating with cross-functional teams to meet business goals.

Qualifications

• Bachelor's degree in engineering or related field with 4+ years of experience.
• CQE, Six Sigma Black Belt, and CRE certifications preferred.
• Experience in the medical device industry and quality systems knowledge desired.
• Proficiency with MS Word, PowerPoint, Excel, Project, and Minitab.

Responsibilities

• Plan, lead, and manage quality deliverables on new product development (NPD) projects per ISO 9001:2015, ISO 13485:2016 and FDA regulations.
• Lead risk management processes and create risk management documentation for NPD projects.
• Create, review and approve documentation for Product Realization Process (PRP) including change requests and design records.
• Facilitate design FMEA and process FMEA; act as SME for quality initiatives.
• Mentor I & II engineers and lead cross-functional quality improvements.

Skills

Quality assurance

Regulatory standards

Risk management

Six Sigma

Cross-functional teamwork

Mentoring

FMEA

Quality systems

Statistical tools

Education

Bachelor's degree in engineering

CQE certification

Six Sigma Black Belt (DMAIC, DMADV)

CRE certification

Tools

Minitab

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Project

Job description

Regulatory Jobs seeks an experienced R&D Quality Engineer III to lead and enforce product development quality initiatives for medical devices. You will drive regulatory compliance, risk management, and documentation across the NPD lifecycle.

Key focus areas include leading FMEA processes, applying Six Sigma methods, and mentoring junior engineers while collaborating with cross-functional teams to meet business goals.