Job Description:

About the Job

The Intern, Quality Assurance assists with quality assurance activities to ensure compliance with CLIA, CAP, FDA, and IVDR regulations and requirements. This position may assist with specific project work related to Design History Files, Post Market Surveillance, Training Strategy, Corrective and Preventive Actions , laboratory compliance, or in collaboration with cross-functional teams to elevate FMI's systems in an efficient and compliant manner.

The intern will contribute to general quality operations and documentation practices, such as data entry, tracking of documents, generating of metrics, and assisting in process improvement efforts. The position will offer opportunities to learn how to obtain, trend, and analyze quality metrics.

The FMI Internship Program is offered to students currently registered in a degree program. It is a 10-12 week summer commitment, Full Time, 40 hours/week. Interns will gain a greater understanding of FMI through challenging project-based work, Spotlight Speaker Series with company executives, and the chance to connect with all employees by attending many company-wide events.

Foundation Medicine is unable to consider candidates that will require visa sponsorship now, or in the future, for this specific role.

Key Responsibilities

• Maintain and assist with updating policies and protocols.

• Gain knowledge of record keeping under medical device and laboratory requirements.

• Support and assist validation documentation activities as required.

• Assist with building systems with Licensure teams to ensure ongoing compliance with laboratory regulations.

• Assist in aspects of the full operation, implementation, and maintenance of quality systems

• Support FDA and other regulatory agency inspections in backroom support/document retrieval.

• Work with management in compiling required metrics and data for monthly Quality meetings and/or management review activities.

• Assist the Post Market function in supporting regulatory compliance for both laboratory and device complaints utilizing our recently implemented electronic system.

• Assist the process for post market data gathering and analysis. Results are presented, on a regular basis, to cross functional leadership to support data driven decisions.

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

Qualifications

Basic Qualifications

• Rising senior enrolled in an accredited college or university pursuing a Bachelor's degree in a life science, engineering, business or equivalent field

Preferred Qualifications

• Prior experience working with Record Management

• Prior experience working with electronic document management and quality management systems

• Current or prospective student in an NAACLS approved Clinical Laboratory Scientist program

• Excellent attention to detail with excellent prioritization and organizational skills

• Superior analytical and problem-solving skills

• Understanding of HIPAA and the importance of patient data privacy

• Commitment to reflect FMI's values: Passion, Patients, Innovation, and Collaboration

#LI-HybridFoundation Medicine, Inc. (FMI) began with an idea - to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI's EEO Statement and EEO is the Law and Supplement . If you have a disability or special need that requires accommodation, please let us know by completing this form . (EOE/AAP Employer)

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