Quality Systems Engineer

Team Description:

Join the 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 who thrives on continuous improvement and is passionate about implementing systems that drive compliance and optimize performance.

Job Description and Responsibilities:

As a Quality Systems Engineer, 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 manufacturing, data collection, nonconformance management, automation of audits and reporting, testing, etc.

• Develop quantifiable metrics displayed in real-time on a dashboard of your choice (e.g., Excel, Grafana, Google Sheets)
• Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills
• Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating the timely closure of actions

You will own subsets of Quality Systems required per ISO 13485 and 21 CFR 820. These include but are not limited to:

• Training Management System (Internal & External)
• Document & Change Control
• CAPAs
• Deviation Management

Required Qualifications:

• Bachelor's degree in Engineering or a related field
• Demonstrated ability to develop and optimize processes for efficiency and compliance
• Understanding of engineering fundamentals
• Proficiency in basic coding and querying
• Strong analytical skills with the ability to create quantifiable metrics
• Excellent communication and collaboration abilities
• Hunger for continuous improvement
• Problem-solving mindset

Preferred Qualifications:

• Background in Biomedical or Electrical Engineering
• 1-3 years of experience in Quality Systems
• Experience with Operational Excellence projects
• Familiarity with Six Sigma principles and projects