Quality Engineering Intern

LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems.

With guidance and oversight by the QE, performs quality work of a broad nature to achieve successful outcomes of departmental and company objectives. The Intern will assist Quality Engineering in completing tasks to ensure that production and process control activities are conducted in compliance with the company quality system and the international regulations governing medical device manufacturing and distribution.
Will collect and analyze data for use by Quality Engineering in the evaluation of non-conforming products, product disposition and CAPA's to address quality issues.  
The Intern will also assist in general procedure updates required as part of process improvements and on-going maintenance of the Quality Management System.

 The intern will support Quality Engineering for executing the quality engineering activities related to the design and manufacture of the products in compliance with the Quality Management System requirements and the regulations of the countries where the franchise distributes and sells products.  Working on projects related to conformance to the Medical Device requirements of ISO 13485 and FDA 21 CFR Part 11.

Job Duties:

• With respect to Nonconforming product handling, will:
  • Generate the weekly NCR data and communicate this to the designated parties when requested by QE, collect and critically analyze data on nonconforming products identified in production.
  • Assist in analyzing trend data to identify opportunities for future CAPA.
  • Notify suppliers of any non-conformance related to purchased material
• With respect to Analysis of Complaint data and Returned Products, will:
  • Provides support for timely analysis to meet Customer Quality complaint and MDR reporting quality metrics.
• Respects the Health and Safety Regulations in his/her field of competence.
• Performs other duties as may be required by their manager.

Skills & Qualifications:

• Successfully demonstrates an in-depth or breadth of engineering skill(s). 
• Must have proficiency with quality tools such as flowcharts, statistical data analysis, mathematical reasoning.
• Ability to work within a changing environment.
• Ability to work with a wide variety of personnel on all levels and utilize constructive confrontation.
• Ability to analyze and problem-solve.
• Excellent communication (written and verbal) and presentation skills.
• Able to communicate across functional lines.
• Sitting 60-80%, standing & walking 20-40%
• Repetitive work on computer 80%
• Oral and written comprehension.
• Must be able to work in a clean room environment and tolerate chemical odors.
• Must be able to work in a lab environment and tolerate the smell and sight of blood.
• Must be willing to take on related duties as required in support of company and departmental objectives.

Education Requirements:

• Pursuing a Bachelors Degree in Biomedical, Chemical or Mechanical Engineering, must have completed Junior year
• Minimum GPA 3.0