About Clarimed:

Our mission is simple…to SAVE LIVES lost to preventable medical errors. Every year there are over 210,000 preventable medical errors which lead to death. Our goal is to do everything in our power to reduce this number significantly. Following U.S. Food & Drug Administration requirements, we do this by conducting usability studies for testing of medical products.

At Clarimed, we co-create safe and usable medical products with our clients. In our studies, we recruit real-life people and observe them simulating the use of medical products to reveal ways to improve these products for our clients.

“The premiere, human centered development and regulatory practice for medical products, point of care devices, companion and combination products, and SaMD.”

ClariMed was formed with the vision that a unique market opportunity exists to build the leader in human centered regulatory and development services for medical products. We believe that a focus on placing human factors at the core of device development and regulatory pathways translates to a “quality by design” approach that drives outsized value for patients, customers, and shareholders. We also believe that a stronger calibration to risk/benefit is emerging and will continue to be a driver of market clearance and reimbursement, which in turn will lead to clients that place an emphasis on “smarter” development.

Clarimed is an industry leader in Human Factors Engineering for medical products headquartered in Chadds Ford, PA and with sites also in California, Massachusetts, and across the UK. We are looking for someone who wants to make a significant impact in the medical field to not only prevent deaths, but also to improve patient care worldwide.

Job Summary 

We are seeking a motivated and detail-oriented Quality Assurance Intern to support our quality services team. This internship provides a unique opportunity to gain hands-on experience in quality assurance processes in the MedTech consulting industry, offering exposure to real-world projects and industry-leading practices. 

  

Key Responsibilities 

  • Assist in implementing and monitoring quality assurance procedures and guidelines for client projects 

  • Support the execution of internal and supplier quality audits, including data collection and reporting 

  • Help maintain and organize documentation related to quality processes, standards, and regulatory compliance 

  • Participate in cross-functional team meetings to understand quality requirements across various MedTech projects 

  • Assist in preparing materials for client quality orientation and training programs 

  • Support the investigation of quality-related issues and help document findings 

  • Contribute to continuous improvement initiatives by actively participating in team projects and discussions 

  • Assist in the development and implementation of Quality Management Systems (QMS) tailored to client needs 

  

Learning Opportunities 

  • Gain practical experience in quality assurance methodologies and best practices specific to the MedTech industry 

  • Develop a solid understanding of industry regulations and standards related to medical device quality 

  • Learn about various quality management tools and techniques used in consulting projects 

  • Enhance analytical and problem-solving skills in a real-world business environment 

  • Improve communication skills through interactions with cross-functional teams and potentially with client-facing opportunities 

  • Exposure to ClariMed's key service areas: 

  • Internal/Supplier Audits 

  • QMS Implementation 

  • Document Management 

  • Regulatory Compliance 

  

Requirements 

  • Currently pursuing a Bachelor's degree in Engineering, Quality Management, Biomedical Engineering, or a related field 

  • Strong attention to detail and analytical thinking  

  • Excellent organizational and time management abilities 

  • Proficiency in Microsoft Office suite, particularly Excel 

  • Ability to collaborate effectively in a team environment 

  • Genuine interest in quality assurance and continuous improvement methodologies in the MedTech industry 

  • This is an onsite internship, all interns must be located in San Jose, CA.  

  

Preferred Qualifications 

  • Familiarity with quality management systems or standards (e.g., FDA CFRs, ISO 13485, ISO 9001) 

  • Basic understanding of statistical analysis and its application in quality assurance 

  • Knowledge of or interest in human factors engineering in medical device development 

  

This internship is an excellent opportunity for students aspiring to kickstart their career in MedTech quality assurance. You will work closely with our quality services team, contributing to real client projects while gaining valuable industry experience and insight into various aspects of quality management in a professional consulting setting.