Person, Text, Face

 

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.

 

Senior Quality Assurance Engineer

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Senior Quality Assurance (QA) Engineer in the Quality Assurance department is a key and critical role at FMI. This position works with various teams within FMI. When working with Product Development teams on new product and design change projects, this role supports deadlines for submission of Bioanalytical plans and reports for Premarket Approvals and supplemental PMAs. As part of the Lab Operations Quality team, this role supports day-to-day quality management laboratory activities that provide the insights that directly help doctors match patients to more treatment options. Within the Quality Systems team this role partners with all parts of the organization, ensuring that the FMI Quality Management System is dynamic, effective, and compliant in order to create a competitive advantage for FMI. This position supports the planning and work of multiple project and scrum teams with a big picture mindset and is accountable for achieving all related business goals.

Key Responsibilities

  • Participate in the development and approval for design and development documents, quality system procedures, and laboratory documentation and controls.
  • Be a subject matter expert for audit-related questions within their subject matter area including front room and back room support and management for FDA, Notified Body, or pharma partners.
  • Ensure all activities are conducted in compliance with the FMI Quality Management System, appropriate regulations, and international and national regulations and are aligned with regulatory agency expectations.
  • Effectively collaborate with a fully integrated team 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 (NCR).
  • Conduct 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.
  • Review and approve equipment and process validation protocols as necessary, including requalification activities.
  • Be responsible for SOP initiation/review/approval.
  • Train new hires for respective areas of responsibility.
  • Report on QA Lab Operations Key Process Indicators (KPI), as applicable.
  • Perform material release activities as necessary.
  • Lead projects and project teams as required.
  • Other duties as assigned.

Qualifications

Basic Qualifications

  • Bachelor’s Degree in a science or engineering discipline and 5+ years of experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry; OR
  • Master's Degree in a science or engineering discipline and 3+ years of experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry

Preferred Qualifications

  • Advanced Degree in the Sciences, Engineering, Business or a related field
  • Experience with next generation sequencing methodology
  • Experience with IVD, Medical Device product development, analytical validation and product approval, manufacturing and/or lab operations
  • Demonstrated ability to lead, communicate, interact and influence effectively at technical levels across functions
  • Demonstrated capacity to work in a fast-paced environment with strong attention to detail
  • Evidence of knowledge of molecular biology
  • Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international; in particular, standards set forth by the International Electrotechnical Commission and International Organization for Standardization
  • Deep knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards
  • Comprehensive knowledge of Good Manufacturing Practices and Good Documentation Practices
  • Working knowledge of Next Generation Sequencing
  • Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
  • Proficiency in relevant analytical methodology and emerging new technologies
  • Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team
  • Strong skills in troubleshooting and problem solving
  • Understanding of HIPAA and importance of privacy of patient data
  • Commitment to FMI values: patients, innovation, collaboration, and passion

#LI-Onsite

About Foundation Medicine

Foundation Medicine 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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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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