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QA Engineer II

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

About the Job

The QA Engineer II works within in the Quality Systems department is a key and critical role at FMI. This role works with various teams within FMI. Within the Quality Systems, team this role partners with all parts of the organization ensuring that the FMI Quality Management System, CAPA’s and Non-conformances processes are dynamic, effective, and compliant, creating a competitive advantage for FMI. This position supports the planning and work of multiple projects and scrum teams with a big picture mindset and is accountable for achieving all related business goals.

Key Responsibilities

• Extensive experience in supporting, identifying and improving current Quality Management System

• Provides guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance

• Conduct periodic reviews to assess QMS adherence to domestic and international Good Manufacturing Practice (GMP) regulations, current GMPs, and company policies.

• Identify and guide the organization on strategy and implementation of continuous improvement and harmonization of the quality system across all sites.

• Works independently and directly with all departments to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

• 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.

• Proficient in conducting 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.

• Responsible for developing, measuring and monitoring key KPI’s

• Travel up to 15% of the time

• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree or equivalent years of experience

·   Bachelor’s Degree with 5+ years of experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry;

·   Or 10+ years with equivalent experience.

• Master’s Degree with 3+ years of experience

Preferred Qualifications

• Degree in the Sciences, Engineering or Business-related field

• Experience with IVD, or Medical Device Quality Systems

• Advanced 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

• Extensive knowledge of Good Manufacturing Practices

• Proficiency in CAPA and Root Cause Investigations

• Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint

• Demonstrated ability to lead, communicate, interact and influence effectively quality system changes

• Ability to work in a fast-paced environment with strong attention to detail

• Strong troubleshooting and problem solving skills

• Excellent communication skills and proven 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

 

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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