Team Description:

Join our Quality Systems Team, where our mission is to ensure compliance with relevant regulatory standards by streamlining operations and enhancing efficiency through innovative process development. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations. We seek a dynamic individual with interdisciplinary skillsets who thrives on continuous improvement and is passionate about implementing systems that drive compliance and optimize performance. You will have the opportunity to work cross-functionally to scale the speed and throughput of our company activities.

Job Responsibilities and Description:

Your primary responsibility will be to gather requirements and develop processes with compliance built into their design. These processes will eliminate variables, save time, and reduce costs to facilitate rapid iteration and innovation. You will continuously optimize and improve these processes to enhance efficiency over time, moving from one method to another as they are built and optimized. Processes may encompass various areas such as data governance, nonconformance management, document control, automation of audits and reporting, testing, etc. as it pertains to preclinical, clinical, and manufacturing activities. 

• Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills.
• Design systems that increase efficiency, utilize automation, and assess impact changes have on existing workflows.
• Build software within and outside of a lab management system. Assist in maintaining, querying, and analyzing data.
• Develop dashboards that automatically display quantifiable metrics in real-time.
• Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating timely closure of actions.
• Have a clear understanding of how to apply risk assessments.
• Display excellent people skills while working with multiple teams with diverse communication styles. Be an excellent communicator who can effectively translate user needs into design requirements.
• Apply experience in solutions architecture, logistics, project timelines, milestones, and resource management to frameworks.
• Gain a thorough understanding of multidisciplinary domains in order to inform process design.

Required Qualifications:

• Strong understanding of engineering first principles and operations engineering
• Fundamental understanding of how systems work
• Experience designing and implementing software solutions, analyzing data, and creating dashboards
• Proficient in at least one general purpose programming language (e.g. Python, Ruby, C++, Java)
• Able to apply solutions architecture concepts to lead/drive projects to completion
• Ability to identify and resolve inefficiencies in processes
• Meticulous attention to detail and organizational skills leading to thoughtful designs but you know that what matters is delivering an implementable solution that works every time
• Effective collaboration in a cross-disciplinary team environment
• Pursuing a STEM degree or equivalent experience

Preferred Qualifications:

• Experience designing/running tests for a complex system
• Experience with Operational Excellence projects
• Understanding of quality, surgery, animal research, neuroscience, and/or engineering
• Background in Industrial Engineering, Operations Engineering/Research, Systems Engineering, Computer Science, Mechanical Engineering, Bioengineering, or related field