Senior Quality Engineer, Design Assurance (Medical Devices)

Vapotherm; Cincinnati (OH); On-site; USD 120,000 - 150,000; Full time

Job summary

Vapotherm is seeking a Sr. Quality Engineer- Design Assurance in Cincinnati, OH to support new product development and sustaining activities. You will ensure a robust QMS, focusing on both hardware and disposable products, at our Cincinnati facility.

The role requires 5–8 years in medical device manufacturing, on-site work ~4 days/week, and strong risk management skills including FMEA/FTA and regulatory knowledge. Travel minimal, team collaboration essential.

Qualifications

• B.S. in Engineering or Science, or equivalent technical field.
• 5-8 years in Medical Device Manufacturing.
• On-site approximately 4 days per week.
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971.
• Strong attention to detail and ability to work in a fast-paced environment.

Responsibilities

• Quality representative on new product development projects assisting in product design control activities.
• Act as risk management SME and create, with cross-functional input, various risk management documents including Hazard Analysis, FMEA, FTA and Risk Management Report.
• Provide Quality review and approval for market needs, product requirements and specifications/technical drawings.
• Review design verification and validation plans, protocols and reports.
• Review and approval of manufacturing procedure documentation.
• Perform supplier and internal audits as needed.
• Evaluates and monitors manufacturing issues, product concerns, and field complaints to determine opportunities for improving manufacturing and product performance.
• Ability to perform hands-on technical trouble shooting as needed.
• Ensure compliance with Vapotherm's Product Realization and Risk Management Procedures.
• Participate in the execution of Quality functions in compliance with FDA QSRs, ISO 13485, ISO 14971, IEC 60601, EU-MDR, and other national and international quality requirements and standards.

Skills

Quality management

Risk management

FMEA

FTA

Hazard analysis

Statistical methods

Regulatory knowledge

Communication

On-site availability

Medical device manufacturing

Education

B.S. in Engineering or Science

Tools

FMEA software

CAPA systems

Job description

Vapotherm is seeking a Sr. Quality Engineer- Design Assurance in Cincinnati, OH to support new product development and sustaining activities. You will ensure a robust QMS, focusing on both hardware and disposable products, at our Cincinnati facility.

The role requires 5–8 years in medical device manufacturing, on-site work ~4 days/week, and strong risk management skills including FMEA/FTA and regulatory knowledge. Travel minimal, team collaboration essential.