Sr. Quality Engineer - Design Assurance

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

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

PRIMARY 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.
• 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.
• 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.
• Performs other duties as required.

POSITION REQUIREMENTS

• B.S. in Engineering or Science, or equivalent technical field
• 5-8 years in Medical Device Manufacturing
• Ability to be on-site approximately 4 days per week.
• 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
• 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.