Senior Quality Engineer - Medical Device NPD & Risk Mgmt

Vapotherm; Cincinnati (OH); On-site; USD 95,000 - 125,000; Full time

Job summary

Vapotherm is seeking a Sr. Quality Engineer to support new product development and sustaining activities at its Cincinnati, OH facility.

You will help manage design controls, risk analyses, and QA activities for the full product portfolio, including hardware and disposables. Responsibilities include leading risk management, reviewing specs and drawings, conducting design verification/validation reviews, auditing suppliers, and ensuring compliance with FDA QSRs, ISO 13485, ISO 14971 and other

Qualifications

• Bachelor-level engineering/science degree or equivalent technical field is required.
• 5–8 years in medical device manufacturing or equivalent.
• On-site availability ~4 days per week; able to work in a fast-paced environment.

Responsibilities

• Act as quality representative on new product development projects and assist in design control activities.
• Serve as risk management SME and create risk documents including Hazard Analysis, FMEA, FTA and Risk Management Report.
• Provide quality review/approval for market needs, product requirements and specifications/drawings.
• Review and approve design verification and validation plans, protocols and reports.
• Review and approve manufacturing procedure documentation.
• Perform supplier and internal audits as needed.
• Evaluate manufacturing issues, product concerns and field complaints for improvements.
• Hands-on technical troubleshooting as needed.
• Ensure compliance with Product Realization and Risk Management Procedures.
• Participate in FDA QSRs, ISO 13485, ISO 14971, IEC 60601, EU-MDR and other quality standards.
• Other duties as required.

Skills

Statistical methods

Risk management

Quality assurance

Education

B.S. in Engineering or Science

Tools

FMEA

Fault Tree Analysis

Hazard Analysis

21 CFR 820

ISO 13485

ISO 14971

Job description

Vapotherm is seeking a Sr. Quality Engineer to support new product development and sustaining activities at its Cincinnati, OH facility.

You will help manage design controls, risk analyses, and QA activities for the full product portfolio, including hardware and disposables. Responsibilities include leading risk management, reviewing specs and drawings, conducting design verification/validation reviews, auditing suppliers, and ensuring compliance with FDA QSRs, ISO 13485, ISO 14971 and other