Quality Engineer II

Position Title: Quality Engineer II

Location: Mirandola (MO)

A Day in the Life

In the Quality group you will:

• Support New Product Development key project, collaborating with geographically spread team
• Communicates primarily and frequently with internal contacts, to share information, status, needs and issues and may have some involvement in cross functional assignments
• Will be responsible for specific activities, parts of the project or processes within the job area
• Have a focus on objectives to meet the goals of project and assignments, and contribute to the completion of project milestones
• Review and approve deliverables (e.g. requirements, protocols, reports) to meet internal/external requirements and overall project quality objectives
• Makes suggestions on enhancements to Design Control activities and continuous improvement of Quality Management System
• May provide guidance and assistance to entry level professionals

You must Have

• Bachelor’s degree in engineering, Science or Technical Field with 2 years of experience in engineering, Medical Device design, verification, validation and/or quality OR master’s degree in engineering, Science or Technical Field with 1 year of experience in engineering, medical device design, verification, validation and/or quality
• Knowledge of quality systems and quality assurance processes and principles, with a focus on verification, standard testing, risk management activities (e.g. ISO 13485, FDA CFR 820.30, ISO 14971, FMEA techniques)
• Good oral and written communication and interpersonal skills, be fluent in English, written and oral
• Ability to work independently with general supervision
• Ability to work in team and good collaboration attitude

• Methodical, critical thinking and analytical approach to resolve issues.
• Adherence to timelines and result-oriented attitude

It will be nice if you will have one or more of these skills:

• Experience working in an Active Medical Device Industry (e.g., FDA-regulated, ISO 13485)
• Working knowledge of standards for Medical Devices (e.g. ISO 13485, IEC 62304, ISO 60601-1 family)
• Working knowledge of software development life cycle for Medical Devices (e.g. IEC 62304)
• Experience with submission of products to FDA
• Knowledge of ticket/defects management tools (e.g. Jira)
• Experience with active dialysis devices
• Audit experience (front room as SME)
• Knowledge of project management techniques

Why Work with Us? 

Working here is highly rewarding – we have the privilege of helping kidney patients experience greater freedom, improved outcomes and a renewed passion for life. 

It’s essential our team members feel valued, supported and empowered too. That’s why we provide a comprehensive total rewards package and opportunities to grow, develop and give back to the communities where we live and work – helping you reach your potential and enjoy a career full of life-changing possibilities.