Summary
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.
Requirements
- 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
Responsibilities
- 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
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 or related field
Benefits
- Excellent medical, dental, and vision insurance through a PPO plan
- Paid holidays
- Commuter benefits
- Meals provided
- Equity + 401(k) plan *Temporary Employees & Interns excluded*
- Parental leave *Temporary Employees & Interns excluded*
- Flexible time off *Temporary Employees & Interns excluded*