About the Job
The Senior QA Specialist, Post Market Surveillance is responsible for implementing, documenting, and reporting post market surveillance data in compliance with FMI processes. This role leads timely complaint investigations, adverse event reporting, and recall management for FMI. The Senior QA Specialist works closely with cross functional teams within FMI to promote post market surveillance awareness and global complaint management requirements. This may include communicating with the FDA for recalls, MDRs, periodic updates, etc. Additionally, this role is responsible for supporting relationships with FMI partners in post market surveillance matters to meet quality agreement commitments.
• Partner with FMI Client Services and Operation management to facilitate complaint investigations and closure across all FMI sites.
• Partner with cross functional team members to promote proper investigation and timely reporting.
• Assist the Director of Post Market Surveillance (PMS) as a Subject Matter Expert on post market surveillance matters when needed
• Participate in continuous improvement activities with the FMI sites to improve efficiencies in post market activities.
• Support FMI IT projects impacting the post market function and/or systems (eQMS).
• Support the facilitation and execution of a regularly scheduled complaint meeting with cross-functional groups evaluating customer feedback and escalate any potential issues in a timely manner and per process.
• Oversee complaint investigations, ensuring that all process requirements are met and documented in a timely manner.
• Ensure FMI employees follow PMS documentation required in FMI processes for compliance to global regulatory requirements
• Become the subject matter expert for complaint management during external audits/inspections by regulatory authorities (i.e. Notified Bodies, FDA, etc.).
• Maintain availability to work outside of regularly scheduled shift.
• Other duties as assigned.
• Bachelor’s Degree with 5+ years of experience in medical device, diagnostics, or biopharmaceutical industry with direct involvement in Post Market Surveillance; OR,
• Master’s Degree with 3+ years of experience
• Degree in science or engineering discipline
• Working knowledge of ISO 13485, FDA CFR 820, FDA CFR 806, FDA CFR 803 and emerging standards and regulations related to post market and vigilance activities (IVDR)
• Knowledge of laboratory standards CLIA, CAP, ISO 15189, NY state and post market requirements
• Knowledge of IVD device complaint management and post market surveillance
• Continuous improvement experience (6 Sigma, Lean, GreenBelt/Black Belt)
• Demonstrated use of time management skills to drive individual/team projects to scheduled completion
• Ability to work in a matrixed organizational structure, developing strong relationships with all levels of management
• Ability to manage timelines and work independently to meet timelines as required
• Strong data analysis skills
• Strong interpersonal, verbal, and written communication skills
• Exceptional organizational, negotiation, and problem-solving skills
• 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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