The responsibilities include assisting with the development of quality systems, procedures and controls to ensure that products consistently meet performance and quality specifications. The Quality Engineer is a leader and strong technical resource who will quickly, effectively and permanently resolve quality problems both internally at Vapotherm and externally at customers and suppliers.
• Works closely with R&D to ensure robust quality specifications for new products.
• Assists in writing, reviewing and executing design and process verification and validations.
• Assists in preparation and updates of manufacturing procedure documentation, and quality procedure documentation.
• Analyzes Non-conformance event and complaint data analysis, investigates to determine root cause, proposes improvements, and maintains CAPA documentation.
• Writes new procedures and work instructions or update the existing documents to drive process improvement.
• Evaluates and monitors manufacturing issues, product concerns, and field complaints to determine opportunities for improving manufacturing and product performance.
• Assists with incoming materials by confirming specifications; conducting visual and measurement tests
• Assists with the equipment calibration and inspection process.
• Promotes a culture of continuous improvement, reinforces the elimination of process variation and supports business improvement and profitability.
• Assists in internal quality audits and supplier audits
• Bachelor’s degree in Engineering, preferably EE.
• 5 Years (or 3 years with Masters degree) experience in quality engineering position at medical device company.
• Strong attention to detail
• Highly organized
• Effective communication skills
• Ability to work independently or as a team
• Working knowledge of ISO 13485: 2003, 21 CFR, CMDR, other international regulations