Quality Engineer

Stelle nicht auf LinkedIn

🕒 vor 18 Tagen

🗻 New Hampshire – Remote

🗻 New Hampshire – Remote

💵 $95.000 - $105.000 / Jahr

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

🔧 QA-Ingenieur (Qualitätssicherung)

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Venus AI LLC

WebsiteLinkedInAlle Stellen

1 - 10 Mitarbeiter

Gegründet 2023

💼 Beratung

📣 Marketing

🤖 Künstliche Intelligenz

Consulting • Marketing • Artificial Intelligence

Venus AI GmbH ist ein auf künstliche Intelligenz fokussiertes Unternehmen, das KI-gesteuerte Lösungen und Dienstleistungen entwickelt und einsetzt. Das Unternehmen legt besonderen Wert auf den Einsatz von maschinellem Lernen und datengetriebenen Techniken, um Organisationen bei der Automatisierung von Arbeitsabläufen, der Gewinnung von Erkenntnissen aus Daten und der Optimierung von Entscheidungsprozessen zu unterstützen. Venus AI GmbH bietet möglicherweise Beratungsdienste, Modellentwicklung und Integrationsunterstützung für Unternehmen und KMU-Kunden an, die KI-Technologien einführen möchten.

Beschreibung

• Investigate product, supplier, manufacturing, and quality system issues and support resolution activities. • Support CAPA activities, including investigation, root cause analysis, action planning, implementation, effectiveness verification, and follow-up. • Review and assess design, material, supplier, process, and documentation changes for potential quality and regulatory impact. • Support risk management activities, including maintenance of risk management files and assessment of changes that may impact product risk. • Work with Engineering, Operations, and suppliers to identify compliant and practical solutions to quality-related issues. • Support supplier quality activities, including issue investigation, supplier corrective actions, change assessments, and supplier communications. • Participate in internal audits and support external audits and regulatory inspections. • Support maintenance of the Quality Management System, including document control, training, quality metrics, audit readiness, and continuous improvement initiatives. • Review quality records, change orders, engineering documentation, and other quality system records for completeness and compliance. • Track quality actions and help ensure commitments are completed, documented, and sustained. • Serve as a quality resource to Engineering and other functional groups by providing guidance on quality system requirements, risk management, change control, investigations, and corrective actions. • Support onboarding of new suppliers and contract manufacturers as required. • Identify opportunities to improve quality system processes and overall operational effectiveness.

🎯 Anforderungen

• Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical field. • Minimum 5-8 years of experience in Quality Engineering, Quality Assurance, or Quality Systems within the medical device industry. • Working knowledge of FDA Quality System Regulation, ISO 13485, risk management principles, and medical device quality system requirements. • Experience supporting investigations, CAPAs, supplier quality activities, and change management processes. • Experience working cross-functionally with Engineering, Manufacturing, and Regulatory Affairs teams. • Strong technical problem-solving, communication, and organizational skills. • Ability to manage multiple projects and priorities in a fast-paced environment. • Excellent communication and interpersonal skills.

🏖️ Vorteile

• Comprehensive package starting on Day 1, covering medical, dental, vision, life insurance, and a 401(k) match.