Process Quality Engineer
Sterling Engineering - vernon hills, IL
Apply NowJob Description
Process Quality Engineer - Medical Device ManufacturerAbout Us:We are a global leader in designing and manufacturing innovative drug delivery devices, serving the pharmaceutical, biotechnology, and generics industries. Our product range includes eyedroppers, inhalation devices, and auto-injectors. We prioritize patient care by ensuring our devices are ergonomic and deliver accurate dosing.Position Overview:We are seeking a Quality Engineer with CAPA experience and a strong background in medical device manufacturing. In this role, you will manage quality improvement initiatives, lead investigations, and ensure compliance with FDA regulations and ISO 13485 standards.Key Responsibilities:Lead CAPA processes and customer complaint investigations.Identify and complete continuous improvement projects utilizing Six Sigma tools and methodologiesOversee product and process validation, and manage change control activities.Conduct supplier quality audits and maintain quality agreements.Ensure compliance with FDA and ISO standards, supporting internal audits.Collaborate with cross-functional teams and lead training on quality activities.Qualifications:Bachelor's degree in Engineering, Science, or related field.3+ years of experience in Quality Engineering, preferably in medical devices.Strong knowledge of CAPA, FDA regulations, and ISO 13485.Proficiency in Six Sigma tools, SAP, and Microsoft Office.Excellent communication skills and ability to work independently.Why Join Us?Contribute to life-changing healthcare products.Be part of a collaborative and innovative petitive salary and benefits.
Created: 2024-09-20