Careers

Diagnostics For All (DFA) is an exciting non-profit organization focused on improving global health by creating and commercializing very low cost, easy-to-use, point-of-care medical diagnostic devices for underserved populations in the developing world.  Conveniently located in Cambridge, Massachusetts, we are creating a new generation of diagnostic devices using elegantly simple paper-microfluidics technology, originally developed in the labs of Professor George Whitesides at Harvard University. DFA has received several grants to develop this technology from varied sources including the Bill & Melinda Gates Foundation, USAID, and DARPA.  Please learn more at www.dfa.org.

 

DFA is hiring for the following positions.  For a full description, please follow the links below:

 

Quality Associate (QA-001)

 

Quality Systems Engineer (QSE-001)

 

 

 

Quality Associate

 

Position Summary:

 

DFA is seeking a highly motivated full-time, exempt, Quality Associate.  The Quality Associate will perform QC testing, maintain the cGMP compliant inventory system, perform Document Control activities and review manufacturing batch records.

 

This position reports to the Quality Management Systems Manager.

 

Major Duties and Responsibilities:

 

  • Responsible for incoming inspections and testing of raw materials and components.
  • Responsible for performing requisite Quality Control testing for in-process and finished product.
  • Reviews and Releases all standard Finished Product, supports all aspects of the Product Release process.
  • Responsible for the Final Review of all Batch Records and all other relevant documents associated with the batch. This documentation includes but is not limited to Batch Records, Deviation Reports, and investigations, supporting validation documentation, raw material testing and finished product testing.
  • Provides accurate input into the releasability of batches at commitments meeting, the manufacturing status of all products by generating a weekly status report for products.
  • Perform general compliance activities, such as raw material disposition.
  • Participate as part of the QA audit team during Client and Agency audits and inspections.
  • Write cGMP and QSR compliant SOPs.
  • Perform and manage Document Control activities.
  • Perform cGMP training, deviation and OOS result investigations, validation protocol review, product changeover activities, and other compliance activities as assigned.

 

Education/Experience:

 

  • B.S. degree in scientific discipline or equivalent combination of education and experience.
  • Minimum of one year of related Quality Control or Quality Assurance experience, preferably in CDRH-regulated area.
  • Current knowledge of cGMP regulations and industry standards.
  • Working knowledge of MS Word and MS Excel.
  • Must be able to demonstrate excellent oral communication and technical writing skills.

 

How to Apply:

 

The successful candidate will have the opportunity to join a small, passionate team developing a novel technology with the potential to positively impact millions of people in the poorest areas around the world.

 

Diagnostics For All, Inc. is an equal opportunity employer, which welcomes qualified applicants of all races, ethnicities, genders, and sexual orientations.

 

Candidates should submit a resume and cover letter to careers@dfa.org and reference QA-001 in the subject line.

 

No telephone inquiries, please.

 

 

Quality Systems Engineer

 

Position Summary:

 

DFA is seeking a highly motivated full-time, exempt, Quality Systems Engineer.  The Quality Systems Engineer will maintain the cGMP compliance systems and ensure compliance of all operations to in-house specifications/standards and cGMP.

 

Major Duties and Responsibilities:

 

    • Conduct internal audits of cGMP operating groups as necessary to ensure compliance to cGMP and internal procedures and policies.
    • Responsible for incoming inspections and testing of raw materials and components.
    • Responsible for performing requisite Quality Control testing for in-process and finished product.
    • Reviews and releases all standard Finished Product, supports all aspects of the Product Release process.
    • Responsible for the Final Review of all Batch Records and all other relevant documents associated with the batch. This documentation includes but is not limited to Batch Records, Deviation Reports, and Investigations, supporting validation documentation, raw material testing and finished product testing.
    • Provides accurate input into the releasability of batches at commitments meeting, the manufacturing status of all products by generating a weekly status report for products.
    • Conduct external audits of raw material vendors, contracting laboratories, and contracting service providers as necessary.
    • Perform general compliance activities, such as raw material disposition, report data integrity audit, equipment and process review, and SOP compliance review.
    • Participate as part of the QA audit team during Client and Agency audits and inspections.
    • Write cGMP and QSR compliant SOPs.
    • Perform cGMP training, deviation and OOS result investigations, validation protocol review, product changeover activities, and other compliance activities as assigned.

 

Education/Experience:

 

  • B.S. degree in scientific discipline or equivalent combination of education and experience.
  • 4 years of related Quality Assurance experience, preferably in CDRH-regulated area.
  • Current knowledge of cGMP regulations and industry standards.
  • Working knowledge of MS Word and MS Excel.
  • Must be able to demonstrate excellent oral communication and technical writing skills.

 

  • How to Apply:

     

    The successful candidate will have the opportunity to join a small, passionate team developing a novel technology with the potential to positively impact millions of people in the poorest areas around the world.

 

Diagnostics For All, Inc. is an equal opportunity employer, which welcomes qualified applicants of all races, ethnicities, genders, and sexual orientations.

 

Candidates should submit a resume and cover letter to careers@dfa.org and reference QSE-001 in the subject line.

 

No telephone inquiries, please.

 

Back To Top

Diagnostics For All is an equal opportunity employer.