Quality Intern

Company & Culture

Welldoc is at the forefront of digital health, driven by a powerful mission: empowering better cardiometabolic health through AI-powered, personalized digital tech, with a vision to be the leading advanced AI digital technology partner across the healthcare industry. We're a team passionate about leveraging cutting-edge science to improve lives, united by core values of collaborative innovation, accountability to excellence, customer focus, efficiency, and unwavering integrity, quality, and safety.

 

At Welldoc, you'll thrive in a collaborative and innovative environment where your contributions directly impact our mission. Recognized as a Great Place to Work for the past four years and named to Modern Healthcare’s Best Places to Work 2025, as well as being an industry thought leader featured at SXSW and in the Wall Street Journal and Economist, we invite you to make a real difference in healthcare with us.

 

Job Purpose

To support Quality Assurance and Regulatory Affairs activities to ensure compliance to FDA 21CFR820, MDSAP, ISO 13485 and EU MDR requirements. This internship is available immediately for approximately 15-20 hours/week and will last between four and six months depending on projects and schedules.

 

Responsibilities

 

• Assist with the maintenance and organization of quality management system documentation.
• Help with internal and external audit preparation and follow-up activities.
• Conduct research on new and updated medical device regulations and standards.
• Contribute to the development and revision of Standard Operating Procedures (SOPs), work instructions and processes.
• Conduct root cause investigations and create CAPA plans for nonconformances identified in the process.
• Assist in tracking and trending quality data, including non-conformances and CAPAs.
• Assist in maintenance of electronic quality management system (eQMS).
• Perform other assigned duties to support the quality department.

 

Required Skills & Experience

• Basic understanding of quality management systems
• Strong analytical, conceptual, and problem-solving abilities.
• Excellent attention to detail and organizational skills.
• Proficiency in Microsoft Office suite (Word, Excel, PowerPoint) and Google Docs
• Must have proficiency in using medical device-related electronic quality management system (eQMS).
• Strong written and verbal communication skills.
• Excellent project management, interpersonal, teamwork, and time management skills.
• Driven team member with multitasking and prioritization skills.
• Agile, responsive, and eager to learn.
• Familiarity with ISO 13485 and medical device regulations (US, Canada, Japan, Australia, EU) or a strong desire to learn.
• Knowledge of standards such as ISO 14971, IEC 62304, IEC 62366, or cybersecurity standards such as ISO / IEC 27001 is a plus.

 

Welldoc operates in ISO 13485 and MDSAP regulated and HITRUST and SOC 2 Type II compliant environments.  Therefore, it is expected that all employees will have either prior experience working in those environments or will be trained to understand the requirements needed to work and support those requirements and culture as they relate to individual roles and responsibilities.

 

Required Education                                   

• Currently pursuing a bachelor's degree in a relevant field such as Biomedical Engineering, Regulatory Affairs, Quality Assurance, or a related scientific discipline.

 

Compensation & Benefits

The anticipated salary range for this position is between $20-25/hour with the expectation that most candidates will fall around the midpoint of the range. Exceptional candidates may exceed the range if education and experience warrant.