Sr. Quality Engineer- Design Assurance

About the role

The Sr. Quality Engineer will primarily focus on supporting new product development and sustaining activities while maintaining the effectiveness of the overall QMS at our Cincinnati, OH facility. This position supports Vapotherm’s complete product portfolio, with emphasis on both hardware and disposable products.

Responsibilities

• Serve as Quality representative on new product development projects, assisting in product design control activities.
• Act as risk management subject-matter expert; create risk management documents including Hazard Analysis, FMEA, FTA, and Risk Management Report with cross-functional input.
• 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 approve manufacturing procedure documentation.
• Perform supplier and internal audits as needed.
• Evaluate and monitor manufacturing issues, product concerns, and field complaints to identify opportunities for improving manufacturing and product performance.
• Perform hands-on technical troubleshooting as required.
• Ensure compliance with Vapotherm’s Product Realization and Risk Management Procedures.
• Participate in Quality functions in compliance with FDA QSRs, ISO 13485, ISO 14971, IEC 60601, EU-MDR, and other national and international quality requirements and standards.
• Perform other duties as required.

Requirements

• B.S. in Engineering or Science, or equivalent technical field.
• 5–8 years of experience in Medical Device Manufacturing.
• Ability to be on-site approximately 4 days per week.
• Working knowledge of risk management tools (e.g., FMEA, Fault Tree Analysis, Hazard Analysis).
• Customer-focused Quality perspective.
• Working knowledge of statistical techniques.
• Knowledge of 21 CFR 820, ISO 13485, and ISO 14971.
• Strong attention to detail.
• Effective communication skills.
• Ability to work as part of a team or independently in a changing, fast-paced, deadline-driven environment; must be able to accept new challenges and continually strive for improvement.