R&D Quality Engineer II – Medical Devices

Regulatory Jobs; Ohio; On-site; USD 75,000 - 95,000; Full time

Job summary

Regulatory Jobs in the United States seeks an R&D Quality Engineer II to lead product development quality initiatives, ensuring robust design and manufacturability of medical devices in alignment with ISO 9001, ISO 13485, ISO 14971 and FDA requirements.

You will mentor co-ops and junior engineers, drive FMEA processes, support audits, and collaborate with cross-functional teams to deliver quality improvements and compliant documentation.

Qualifications

• Bachelor's degree in engineering or related field with 2+ years of relevant experience.
• Six Sigma Black Belt certification preferred.
• Strong written and verbal communication and analytical abilities.

Responsibilities

• Lead quality deliverables on new product development (NPD) projects per regulatory standards (ISO 9001:2015, ISO 13485:2016, ISO 14971, FDA, CSA, EU MDR).
• Facilitate design FMEA and risk management processes across development teams.
• Create, review, and approve documentation for Product Realization Process (change requests, test specs, design records).
• Mentor co-ops and engineers, driving technical skills and collaboration.

Skills

Communication

Analytical skills

Problem solving

Risk decision making

Education

Bachelor's degree in engineering or related field

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Microsoft Project

Minitab

Job description

Regulatory Jobs in the United States seeks an R&D Quality Engineer II to lead product development quality initiatives, ensuring robust design and manufacturability of medical devices in alignment with ISO 9001, ISO 13485, ISO 14971 and FDA requirements.

You will mentor co-ops and junior engineers, drive FMEA processes, support audits, and collaborate with cross-functional teams to deliver quality improvements and compliant documentation.