Quality Assurance (QA) Intern
Company: Fasikl Inc.
Location: Bloomington, MN
Department: Quality Assurance
Reports to: Sr. Quality Specialist
Working Conditions: On-site; 8 hours/day
Fasikl, Inc. is a pioneering neuro-AI company dedicated to developing advanced artificial intelligence technologies that transform the way neurological diseases are treated. Founded in 2019 as a spin-off from the University of Minnesota, Fasikl leverages its proprietary platform to capture neural signals directly from peripheral nerves and to train disease-specific neuro-AI models, enabling therapies that are more effective, safe, and convenient.
We are seeking a QA Intern to support Quality Management System (QMS) activities for Fasikl. This position will be assisting with complaint handling, nonconformances and Corrective Action and Preventive Action (CAPA), quality record review, quality data analysis, and continuous improvement initiatives. This position provides hands-on experience in medical device quality systems and supports the implementation and maintenance of processes compliant with applicable quality standards, including ISO 13485, FDA Quality Management System Regulation (QMSR), and company procedures.
The QA Intern assists Sr. Quality Specialist by performing assigned quality activities, maintaining accurate documentation, supporting audit readiness efforts, and helping ensure quality processes are effectively implemented. The position requires quick-learning, attention to detail, strong organizational skills, and the ability to support changing business priorities while performing activities within established procedures and assigned training.
Responsibilities/Duties
- Complaint Handling and Customer Feedback Support
- Assist with compliant intake, tracking, and documentation activities.
- Review and investigate customer feedback and complaint records for completeness, accuracy, and appropriate documentation.
- Escalate potential product quality concerns or trends to the Senior Quality Specialist for evaluation.
- Nonconformance and CAPA Support
- Assist with initiating and submitting nonconformances and CAPA activities.
- Identify, review and investigate product and quality issues, and propose plans and resolutions for correction and mitigation.
- Track and close nonconformances and CAPAs.
- Quality Data Review and Reporting
- Collect, organize, and analyze quality-related information.
- Support review of quality metrics, including but not limited to customer complaints, nonconformances, CAPAs, supplier performances, product quality trends, etc.
- Prepare quality reports as per the internal procedures.
- Support identification of trends, recurring issues, and opportunities for improvement.
- General QMS Support
- Support implementation and maintenance of QMS processes under the direction of Sr. Quality Specialist.
- Assist review of QMS documents, including standard operating procedures, work instructions, forms, and quality records.
- Support quality system improvement activities by identifying gaps and bridging them as necessary.
- Assist with preparation of audit readiness for internal and external audits.
Minimum Education
- Currently pursuing a master’s degree in quality management, regulatory affairs, or relevant field.
- Must have completed 1-year of program.
- Graduate students in related fields may be considered.
Background/ Experience
- Previous coursework or experience in quality systems, data analysis, technical documentation, medical device or pharmaceutical products.
- Interest in medical device quality systems, regulatory compliance, or healthcare technology.
- Proficient in Microsoft Office Suite.
- Knowledge of ISO 13485, 21 CFR Part 820, and other medical device regulations.
- Knowledge of good documentation practices.
Desirable Attributes/Skills
- Strong attention to detail.
- Strong organizational and documentation skills.
- Ability to analyze information and identify trends.
- Effective written and verbal communication skills.
- Ability to work with collaboration and independently, as needed.
- Professional attitude and commitment to quality.
Contact Information
Human Resources: Rakshitha Chilukani - [email protected]
Education:
Work Location: In person
