Senior Quality Assurance Engineer

1 week ago

Cincinnati, Ohio, United States Vapotherm Full time
Job Summary

We are seeking a highly skilled Senior Quality Engineer to join our team at Vapotherm. As a key member of our quality team, you will be responsible for supporting new product development and sustaining activities while maintaining the effectiveness of our Quality Management System (QMS).

Key Responsibilities
  • Provide quality representation on new product development projects, assisting in product design control activities.
  • Act as a risk management subject matter expert, creating various risk management documents, including Hazard Analysis, FMEA, FTA, and Risk Management Reports.
  • Review and approve market needs, product requirements, and specifications/technical drawings.
  • Responsible for reviewing design verification and validation plans, protocols, and reports.
  • Review and approval of manufacturing procedure documentation.
  • Perform supplier and internal audits as needed.
  • Evaluate and monitor manufacturing issues, product concerns, and field complaints to determine opportunities for improving manufacturing and product performance.
  • Quality representative for project-specific data at monthly Quality Data Review with Executive Management.
  • 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.
Requirements
  • B.S. in Engineering or Science, or equivalent technical field.
  • 5-8 years in Medical Device Manufacturing.
  • Ability to be on-site approximately 3 days per week (long term). Ability to be on-site approximately 4 days per week for first month(s) of employment.
  • Working knowledge of various Risk Management tools (i.e. FMEA, Fault Tree Analysis, Hazard Analysis).
  • Customer Focused Quality perspective.
  • Working knowledge of statistical techniques.
  • Knowledge of 21 CFR 820, ISO 13485, ISO 14971.
  • Strong attention to detail.
  • Effective communication skills.
  • Ability to work as a team or independently in a changing, fast-paced, deadline-driven environment; must be able to accept new challenges and continually strive for improvement.

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