We're hiring! Quality Systems & Operation Intern

Job Description

PASCALL Systems, Inc. is an early-stage medical device startup developing novel technology spun off from research labs at the Massachusetts General Hospital (MGH) and the Massachusetts Institute of Technology (MIT). We are seeking a dynamic and innovative engineer to develop signal processing algorithms for a next generation wearable brain monitoring system that will be used in patient care.

We are seeking a detail-oriented and proactive Quality Systems & Operation Intern to join our team at PASCALL Systems, Inc. As a startup medical device company, we are committed to delivering high-quality products that meet regulatory requirements and exceed customer expectations. This internship offers a valuable opportunity to gain hands-on experience in quality management systems within the medical device industry. 

Responsibilities  

*Quality Systems: 

• Assist in the development, implementation, and maintenance of quality management systems in compliance with regulations and standards (FDA QSR, ISO 13485). 

• Support document control activities, including document creation, review, approval, and revision. 

• Participate in the investigation of non-conformances and implementation of corrective and preventive actions (CAPAs). 

• Support the training program by coordinating training sessions and maintaining training records. 

• Collaborate with cross-functional teams to ensure quality objectives are met throughout the product lifecycle. 

• Provide support and contribute to other Quality Assurance activities as needed. 

*Operation: 

• Assist CEO and Quality Lead in various operational activities of the company, including support with planning, research, procurement, and scheduling 

• Support with organizing company and team activities 

Qualifications: 

• Strong attention to detail and organizational skills. 

• Excellent written and verbal communication skills. 

• Ability to work independently and collaboratively in a fast-paced environment. 

• Knowledge of quality management systems principles and regulations (e.g., FDA QSR, ISO 13485) is a plus 

Benefits: 

• Direct Interaction with CEO: As a member of our team, you will have the unique opportunity to work with our CEO and other key team members. This direct interaction provides exposure to strategic decision-making processes within a small business environment. 

• Hands-On Experience: This internship offers hands-on experience in quality management systems within the medical device/biotech industry. You will have a unique opportunity to learn and implement elements of the ISO 13485 Quality Management Systems standard that governs medical device development.  

• Flexible Work Environment: We offer a flexible work environment to accommodate your schedule. This hybrid role will provide you with the opportunity to work remotely for the majority of the week, with two days in office, allowing for greater flexibility. 

• Impactful Work: By joining our team, you will be contributing to the development of innovative medical devices that have the potential to improve patient outcomes.  

• Potential for Long-Term Growth: Exceptional performance during the internship may lead to potential long-term opportunities within our company. We value talent and are always looking to identify individuals who can contribute to our mission and growth. 

Job Type

· Intern/Part-time/Full-time

. Starts as soon as March 2024

Work Arrangement

. Hybrid (remote + in-office)

Our office is at 200 Portland St, right next to North Station and 5 minutes away from Massachusetts General-Brigham

Benefits for full-time position

· Medical and Dental Insurance (100% coverage for you and family)

· Stock options

Location preferred

· Boston, Massachusetts

Work Authorization

· United States (required)

· Can work immediately (required)

Posting StatementAll qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, sex, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, military and veteran status, marital status, pregnancy, gender, gender expression, gender identity, sexual orientation, or any other characteristic protected by local law, regulation, or ordinance....