Quality Engineer

Vantedge Medical • Wheeling, IL

2h • Onsite

About The Position

We are seeking a skilled Quality Engineer with a strong background in ISO 13485 to join our team. The ideal candidate will have experience in quality management systems within the precision machining sector, with a particular focus on medical device manufacturing. This role will be critical in ensuring our products meet the stringent quality standards required for regulatory compliance and customer satisfaction

Requirements

• Education: Bachelor’s degree in engineering, Quality Assurance, or a related field preferred.
• Experience: Minimum of 5 years of experience in a quality engineering role, preferably within the precision machining or medical device industry.
• Skills: Strong knowledge of ISO 13485 standards and quality management principles. Experience with risk management, statistical analysis, and root cause analysis techniques. Proficiency in quality tools and software (e.g., Minitab, SPC). Proficiency in Microsoft 365 (Outlook, Word, Excel, PowerPoint, SharePoint, etc.).
• Language: Fluent in English.
• Other: Strong analytical and problem-solving skills, attention to detail, and the ability to work effectively in a fast-paced, collaborative environment.

Nice To Haves

• Relevant certifications (e.g., CQE, Six Sigma) are a plus.
• Demonstrated expertise in ISO 13485 is highly preferred.

Responsibilities

• Quality Management Systems: Develop, implement, and maintain quality management systems in accordance with ISO 13485 standards. Ensure compliance with regulatory requirements and industry best practices.
• Quality Assurance: Oversee quality assurance activities including the creation and management of inspection plans, control plans, and documentation procedures. Conduct audits, inspections, and tests to verify product quality.
• Continuous Improvement: Drive continuous improvement initiatives within the quality management system. Identify areas for improvement, recommend changes, and lead efforts to enhance product quality and operational efficiency.
• Non-Conformance Management: Investigate and manage non-conformances, including root cause analysis and corrective action planning. Ensure timely resolution and implementation of corrective and preventive actions (CAPA).
• Documentation: Ensure all quality documentation, including work instructions, standard operating procedures (SOPs), and records, are accurate, up-to-date, and compliant with ISO 13485 and other relevant standards.
• Training and Support: Provide training and support to production and engineering teams on quality standards, processes, and best practices. Foster a culture of quality awareness and responsibility across the organization.
• Supplier Quality Management: Assess and manage supplier quality performance. Collaborate with suppliers to resolve quality issues and ensure the quality of incoming materials and components.
• Regulatory Compliance: Stay current with regulatory requirements and industry standards related to precision machining and medical device manufacturing. Ensure that the company’s practices are compliant with relevant regulations.
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level