Quality Engineer I

CIVCO Medical Solutions • Coralville, IA

75d

About The Position

Coordinates and executes projects to improve quality, engineering, and production systems. This position will support new product development (NPD), continuous improvement initiatives, Quality Management System (QMS) compliance, production operations, and post-market activities including complaint handling, nonconformances, and CAPA.

Requirements

• Minimum of a bachelor's degree (BS) in engineering from a four-year college or university.
• One to two years related experience and/or training; or equivalent combination of education and experience.
• Demonstrates documentation, process management, root cause investigation, quality analysis tool, and troubleshooting/problem solving skills.
• Demonstrates interpersonal and self-management skills.
• Experience with Microsoft Office (Excel, Word, PowerPoint, Outlook, Teams).
• Must possess strong organizational skills and attention to detail.
• Regular attendance is required for the ability to complete work.
• Requires face-to-face interaction with team members, peers and management to complete work and provide support.

Nice To Haves

• Prefer experience with manufacturing processes such as heat sealing, injection molding, machining and assembly.

Responsibilities

• Ensure compliance with 21 CFR Part 820, ISO 13485, MDSAP, and other relevant standards.
• Lead and document investigation, root cause analysis, and corrective action plans for quality related issues such as corrective actions, complaints and non-conforming products.
• Responsible for project management and tracking of corrective action plan implementation.
• Support internal and external audits of CIVCO quality system.
• Support establishment and maintenance of quality inspection plans/methods to ensure incoming product meets quality standards per specification documentation.
• Support data collection and reporting on established quality metrics.
• Develop, document, and execute new product verification testing primarily on product line extensions.
• Review and audit product structures, drawings, specifications, and design control documentation for completeness and application to CIVCO ISO 13485 quality system.
• Able to make decisions on simple technical matters related to verification, inspection and testing.
• Supports initiatives to improve product quality metrics.
• Provide quality support for product lifecycle management and product end-of-life activities.
• Able to identify and support operations and quality process improvement projects primarily for small, department level projects.
• Review and support manufacturing equipment and process qualifications including IQ/OQ/PQ.
• Evaluate and determine product disposition for non-conforming product.
• Attends all relevant training.
• Keeps up to date of relevant developments in technology.
• Utilizes statistical techniques and programs to make quality decisions.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees