About the Job
The Quality Engineer II in the Quality Design Assurance department is a key and critical role at FMI. This role presents the incumbent with an opportunity to work with various teams within FMI, such as working with Product Development Teams on new product and design changes projects, supporting projects for companion diagnostic claims including Bioanalytical studies, and reports for Premarket Approvals and supplemental PMAs and other regulatory submission. This position supports the planning and work of multiple project and sub- teams with a big picture mindset, and is accountable for achieving related business goals.
• Participate in the development and approval for design and development documents, quality system procedures, and laboratory documentation and controls.
• Subject matter expert 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, 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, and other areas as applicable to enable specific product development.
• 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.
• Other duties as required.
• Bachelor’s Degree in a science or engineering discipline and 5+ years of experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry; OR,
• Master's Degree in a science or engineering discipline with 3+ years of experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry
• Advanced Degree in the Sciences, Engineering or Business or a related field
• Experience with next generation sequencing methodology
• Experience with IVD, or Medical Device product development, analytical validation and product approval, manufacturing and lab operations
• Demonstrated experience of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international, in particular standards set forth by International Organization for Standardization
• Knowledge of:
• Bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards
• Good Manufacturing Practices
• Next Generation Sequencing, and
• molecular biology
• Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
• Proficiency in relevant analytical methodology and emerging new technologies
• Demonstrated ability to work in a fast-paced environment with strong attention to detail
• Demonstrated ability to lead, communicate, interact and influence effectively at technical levels across functions
• Strong skills in troubleshooting and problem solving
• 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.
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)
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