Lead Quality Engineer
Boston, MA

Job Description

About Foundation Medicine:

Foundation Medicine began with an ideato 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.

Job Description:

Foundation Medicine is looking for a Lead, Technology Quality Management to support our efforts of developing, planning, implementing and insuring that software quality assurance for our In Vitro diagnostic products, medical instrumentation and Clinical lab instrumentation is performed in a consistent and compliant manner across all FMI functional areas including custom SW, Commercial off the shelf software (CoTS) and hybrid LIMS systems. The position will report directly to the Director, Technology Quality Management and will work closely with the Quality Assurance department and the team implementing a secure and quality-based software development life cyle and processes. The position will be based in our new technology location in the Seaport, Boston. Travel for this position is estimated at less than 10% during the fiscal year for both international and domestic locations.

Responsibilities:

* Partners with Technology teams to ensure that computerized quality systems are in compliance with FDA Quality System Regulations, IEC 62304, 21 CFR Part 11, and GAMP5.
* Provides regulatory guidance to modern software development life cycle (SDLC) approaches including Agile, DevOps, continuous integration/continuous deployment (CI/CD), automated testing.
* Insure that all aspects of FMI SW Verification and Validation initiatives including Risk Determination and Analysis, Hazard Analysis, all FMEA activities, traceability matrixes, test execution and development, and resource management SOPs are compliant and followed.
* Accountable to manage and harmonize all QMS SW management processes and ensure the FDA-compliant validation of all SW systems are completed.
* Insure that companywide SW system test and execution are completed throughout the design and development phases of IVD product development and GMP compliant Design and Development procedures are followed.
* Assists in insuring that corporate SW based management tools are used and maintained including defect tracking systems, requirements tracing, test documentation, and resolving defects, as well as providing defect-reporting mechanisms.
* Insure that all FMI software undergoes SW Design, develop and execution of manual and scripted functional tests and are traceable to software specifications.
* Assists in aligning project teams (including project managers, business analysts, experience designers, technologists and business stakeholders) around all aspects of software testing and software quality control processes including scheduling, estimation and issue management.
* Participate in requirements, functional and design specification reviews.
* Participate in customer and regulatory audits as software QA subject matter expert.
* Create/compile validation documentation necessary to meet FDA and international requirements.
* Leads the approval of validation deliverables.
* Performs additional activities related to overall Quality Assurance as requested by Director, Technology Quality Management, e.g. audits, vendor qualifications.

Qualifications (Positions Skill Set):

Required:

* Bachelor's degree.
* Minimum of 7 years of practical work experience defining, documenting and executing software/system verification and validation.
* Minimum of 7 years of experience working in disciplined regulated industry and in the application of automated technology, particularly 21 CFR, ISO 13485, IEC 62304, GAMP 5 and Design Controls experience.
* Solid understanding of software development life cycle, methodologies and best practices including Agile.
* Familiarization with product documentation.
* Experience with defect tracking systems, and defining and tracking software.
* QA metrics.

Preferred:

* Ability to understand interdependencies and relationships among software and system components.
* Knowledge of Information Security requirements including ISO 27001 and SSAE16 SOC 2.
* Experience working within a Clinical Lab Systems setting.

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.