Quality Engineer/Shopfloor Support Specialist

Company Description Incipio Devices is an orthopedic device company focused on solution-driven approaches to commercial products, contract manufacturing, and contract development. The organization works closely with customers to design and produce high-quality orthopedic solutions that meet clinical and regulatory requirements. Team members collaborate across engineering, quality, and manufacturing to bring innovative products to market efficiently and safely. Applicants can expect a dynamic environment that values technical excellence, reliability, and continuous improvement in medical device production. Additional information about the company and its products is available on the Incipio Devices website.
Role Description The Quality Engineer/Shopfloor Support Specialist is a full-time, on-site role based in Huntington, IN. This position supports daily manufacturing operations by monitoring product quality on the shop floor, investigating nonconformances, and working with production teams to resolve issues promptly. The role includes performing quality inspections, reviewing documentation and records, and ensuring adherence to standard operating procedures and applicable regulations. The specialist collaborates with engineering and manufacturing to implement corrective and preventive actions, improve processes, and maintain quality system compliance. Additional responsibilities include supporting internal audits, training shopfloor personnel on quality standards, and contributing to continuous improvement initiatives that enhance product reliability and production efficiency.
Qualifications

• Demonstrated skills in Quality Engineering and Quality Management to design, maintain, and improve quality systems and processes.
• Experience in Quality Control and Product Quality to perform inspections, measurements, and shopfloor checks ensuring products meet specifications.
• Background in Quality Assurance to manage documentation, support audits, and ensure compliance with medical device standards and regulations.
• Ability to collaborate effectively with manufacturing, engineering, and cross-functional teams in a shopfloor environment.
• Strong analytical and problem-solving abilities, including experience with root cause analysis and corrective/preventive actions (CAPA).
• Familiarity with orthopedic or medical device manufacturing, including relevant industry standards (e.g., ISO 13485, FDA QSR), is preferred.
• Proficiency in reading technical drawings, specifications, and using basic measurement tools and quality software.
• Associate or bachelor’s degree in engineering, quality, or a related technical field, or equivalent practical experience in a regulated manufacturing environment.