Senior Quality Assurance Specialist

3 days ago


Cincinnati, Ohio, United States Vapotherm Full time
Job Summary

The Senior Quality Engineer will play a critical role in supporting new product development and sustaining activities while maintaining the effectiveness of the overall Quality Management System (QMS). This position will be responsible for ensuring compliance with regulatory requirements and industry standards, including FDA QSRs, ISO 13485, and ISO 14971.

Key Responsibilities
  • Provide quality review and approval for market needs, product requirements, and specifications/technical drawings.
  • 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.
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.
Working Environment

The Senior Quality Engineer will work in a fast-paced, deadline-driven environment and must be able to accept new challenges and continually strive for improvement.



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