||Sr. Quality Analyst
The incumbent is responsible for reviewing clinical and product complaints for patient safety, adverse events, serious adverse events and regulatory reportability in compliance with global postmarket surveillance regulations. This person must have a high level
of knowledge of the FDA and Global regulations governing complaints, Medical Device Reporting and Drug Reporting. This person will be a positive, solution focused individual with the ability to work independently and as a committed team player.
• Conduct thorough clinical and product complaint investigations as assigned for customer reported device related incidents.
• Interface with customer clinical staff to obtain detailed information regarding reported incidents as required. Maintain patient confidentiality.
• Consult with NxStage Clinical Staff as required.
• Responsible for Reportability Decisions and filing reports to regulatory agencies – e.g. FDA MedWatch, EU Vigilance, Health Canada Problem Reports.
• Full adherence to NxStage policies and procedures outlining complaint handling functions.
• Regular reporting to management of complaint trends.
• Ensure that complaints are recorded and closed-out in a timely manner as accurately as possible.
• Incorporate device knowledge and drug knowledge, including knowledge of device labeling into decision making process for adverse events and serious adverse events.
• Conduct and Review Health Hazard Risk assessments as assigned.
• Other duties as assigned.
||Education & Qualifications:
• Bachelor’s degree in a science or engineering field or equivalent level of experience in medical device industry. Clinical Experience in dialysis desired.
• 6+ years experience in medical device industry.
• Demonstrated knowledge of Global regulations governing complaints, Medical Device Reporting and Drug Reporting desired.
• Exceptional attention to detail and follow-through.
• Assumes responsibility for managing multiple priorities, meeting deadlines and commitments in a quality-oriented, results-focused manner
• Excellent verbal and written communication skills across different business groups, including engineering and customers
• Overall positive and optimistic attitude
- Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
- Please view Equal Employment Opportunity Posters provided by OFCCP
- The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access
to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure
is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41
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