Principal Engineer, Quality

The Principal Engineer will be supporting the quality and regulatory related matters associated with the medical bed devices. In this role you will also be responsible overseeing and/or assisting with a variety of Quality Engineering functions and ensuring compliance with QSR regulations and related policies and procedures. In addition, this position will work to provide the necessary data to make effective quality and business decisions, and implement sound, data-driven solutions that emphasize quality system compliance. You will need to maintain a partnership approach to all tasks and cultivate professional relationships with other departments and outside agencies. Your talent is needed across a wide variety of industries. As a Principal Engineer, you have a wide array of career choices, but are motivated by the opportunity to work in a company that supports innovation, professional development, and a purposeful mission. Serve as a primary point of contact for quality related matters associated with support for medical bed devices. Collaborate with supplier’s engineering and quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements. Work with design engineering to determine receiving inspection requirements of purchased components and finished product. Provide technical quality engineering support to receiving inspection. Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, & PQ). Participate in Corrective Action System activities including evaluation of failure investigation and corrective action plans, root cause analysis and follow-up activities. Ensure accurate and timely processing of all Quality Records along with the company’s regulatory compliance profile per 21CFR820 regulations. Collect, analyze, and track key data across the Batesville manufacturing site related to entity quality and monitor key performance indicators by working with key partners across the corporation. Use quality tools and practices to establish approval criteria to ensure the identification of quality failure concerns for both internal and external manufactured parts and assemblies (e.g., FMEA (Failure Modes Effects Analysis).