Principal Quality Engineer

Primordial Soup, LLC (Psoup) is an ISO 13485 certified product development company located in St. Paul, MN. We design and manufacture products for companies of every shape and size and in a variety of industries, particularly medical devices. The services we provide cover the entire breadth of product development, including concept development, industrial design, mechanical design, electrical design, prototype development, functional testing, verification and validation, regulatory support and ultimately production manufacturing. We have an energetic, fun and creative culture.

Psoup is looking for an experienced, hands-on, multi-talented Principal Quality Engineer. The candidate will be responsible for directing the quality functions of the company, including refining and implementing the quality management system, performing the quality role on certain product development projects and overseeing the proper execution of quality procedures during production manufacturing.

Responsibilities

• Developing, implementing and maintaining a quality system consistent with the needs of the company, the needs of our clients, the requirements of ISO 13485, US FDA Quality System Regulation (QSR), and other regulatory bodies
• Promoting the quality policy by providing guidance and training to personnel performing and verifying work affecting quality
• Participating in quality control activities including in-coming, in-process and final inspection and testing, control of inspection/ measuring/test equipment, document and data (record) control, corrective and preventative action, non-conforming product, head the Material Review Board (MRB), supplier evaluations (maintain ASL, monitoring, audits), personnel training & practices, assist top management with job descriptions, internal audits, investigations (of complaints, NCP), maintain Quality System SOPs, forms, and manual
• Working with research and development personnel to develop new products utilizing quality planning and design control techniques, including risk management
• Working with manufacturing personnel to ensure product traceability, control of nonconforming products, process controls, purchasing control, inventory control and training
• Tracking vendor performance for input into the supplier evaluation system
• Analyzing quality data using statistical techniques and trending various elements of the quality system to identify potential corrective or preventive actions
• Executing activities in support of the Quality Policy and objectives

Qualifications

• A bachelor’s degree in a related technical area
• A minimum of eight years of quality assurance experience for medical devices, preferably working in design and manufacturing environments
• Experience with ISO 13485 and FDA QSR (Part 820)
• Experience writing quality policies, procedures, work instructions, and specifications