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Every patient sample is a story.

That's why our Lab Ops team is focused on providing physicians with comprehensive genomic information about each person's cancer. Information that's as unique as the patients are. The insights discovered in our labs may help change their story.

 

Associate Quality Engineer

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Associate QA Engineer works within the Quality Systems department at FMI and collaborates with various teams across FMI. This role partners with all parts of the organization to ensure that the FMI Quality Management System, CAPA’s and Nonconformances processes are effective and compliant. This position supports Quality team members in achieving all related business goals.

Key Responsibilities

  • Support Quality Management System.
  • Support the implementation of continuous improvement and harmonization of the quality system across all sites.
  • Effectively collaborate cross-functionally to facilitate the completion of documents.
  • Maintain Quality Management Systems for functional area including Design Controls, Software Development, Risk Management, Corrective and Preventative Action (CAPA) system and Non- Conforming Material Reports.
  • Support root cause analysis and implementation of correction, corrective and preventative actions and verification of effectiveness of actions as periodically required in the identification and resolution of issues.
  • Be responsible for developing, measuring, and monitoring key performance indicators.
  • Other duties as assigned.

Qualifications

Basic Qualifications

  • Bachelor’s Degree; OR,
  • 5+ years of equivalent related experience

Preferred Qualifications

  • Degree in the Sciences, Engineering or Business-related field
  • Experience with IVD or Medical Device Quality Systems
  • Knowledge of standards and regulations pertaining to the IVD and/or Medical Device industry, both domestic and international and not limited to FDA QSR 820, ISO13485, ISO15189, CAP/CLIA, & IVD/IVDR
  • Knowledge of CAPA and Root Cause Investigations
  • Knowledge of Good Manufacturing Practices
  • Ability to communicate, interact and influence effectively regarding quality system processes
  • Ability to work in a fast-paced environment with high attention to detail
  • Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
  • Good communication skills and ability to work effectively as a member of a multidisciplinary team
  • Understanding of HIPAA and importance of privacy of patient data
  • Commitment to FMI values: patients, innovation, collaboration, and passion

 

About Foundation Medicine

Foundation 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.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Internal applicants, please use your FMI email address.

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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)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.