Quality Assurance Engineer II
JenzabarFull Time
Junior (1 to 2 years)
Candidates should possess a minimum of 5 years of experience in quality engineering. A strong understanding of customer specifications, industry standards, and regulatory requirements is necessary. Experience with New Product Introduction (NPI) and Quality Management Systems (QMS) is preferred. Familiarity with Corrective and Preventive Action (CAPA) processes is also required.
The Quality Engineer Sr will ensure product compliance with customer specifications, industry standards, and regulatory requirements. This includes approving changes and deviations, leading the creation and maintenance of Master Validation Plans, and supporting NPI documentation. They will serve as the primary customer contact for quality issues, lead responses to customer concerns, and develop customer-defined quality reports. Responsibilities also include providing technical training, ensuring manufacturing quality compliance, leading the development of inspection strategies, and creating Certificates of Compliance. The role involves analyzing quality metric data to reduce scrap and rework, leading CAPA development for systemic issues, and supporting the continuous improvement of the quality management system.
Manufactures and repairs medical devices
Plexus Corp. offers engineering and manufacturing services tailored for medical device manufacturers, focusing on aftermarket repair and maintenance for drug delivery devices. Their services lead to a 50% improvement in turnaround times and a 25% reduction in service costs, while also minimizing quality issues. Plexus stands out by providing end-to-end solutions, utilizing tools like the Strategic Mitigation Action Response Tracker (SMART) to enhance supply chain efficiency. The company's goal is to deliver specialized, high-quality solutions that improve operational efficiency and reduce costs for their clients.