Quality Engineer

Job not on LinkedIn

🔥 1 minute ago

🗻 New Hampshire – Remote

🗻 New Hampshire – Remote

💵 $95k - $105k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Venus AI LLC

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2023

🤖 Artificial Intelligence

Artificial Intelligence

Venus AI LLC is an artificial intelligence-focused company that develops and deploys AI-driven solutions and services. With an emphasis on applying machine learning and data-driven techniques, the company helps organizations automate workflows, derive insights from data, and enhance decision-making. Venus AI LLC may offer consulting, model development, and integration support to enterprise and SMB clients seeking to adopt AI technologies.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

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