ResponsibilitiesReview, evaluate, classify and perform follow-up activities on all Product Complaints relative to the identity, quality reliability, safety and effectiveness of medical devices. Evaluates for reporting criteria to Government Agencies to determine if the event reasonably suggests a device may have or could have caused or contributed to a death or serious injury.
- Works independently on and resolves complex issues
- Has conceptual understanding of QA functions
- Prioritizes work to meet deadlines
- Suggests and implements tactical direction for functional area
- Investigates and processes product complaints while maintaining compliance to all regulations
- Investigation and documentation of field clinical events and follow-up with Sales Representatives
- Accountable for compliance with all Food & Drug Administration (FDA), European Union Medical Device Directives (MDD) and other regulations governing adverse event reports such as Medical Device Reports (MDR), Medical Device Vigilance (MDV) and other reports.
- Evaluates Product complaints for MDR/MDV/Other regulatory agencies as applicable
- Under the direction of Department management, is an active participant during internal and external audits
- Devises new approaches to problems encountered
- Document technical operating procedures for system training and user certification
- Together with Supervisor/Manager plan and implement short-term and long-term projects
- Performs planned, periodic audits of Coordinators' and Analysts' work to ensure compliance to departmental procedures and all applicable government regulations
- Documents audit results in written audit reports that are distributed and reviewed by department management
- Work requires a broad knowledge of Cordis products and clinical applications of such products
- Assist with review of analysis reports and preparation of customer responses
- Independently performs assignments with instructions as to the general results expected
- Performs work, which involves conventional complaint handling processes but may include a variety of complex investigations and follow-ups
- Responsible for communicating business-related issues or opportunities to next management level
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance
- Practices company safety, quality policies and procedures, actively requires conformance
QualificationsRequired Qualifications
Requires a minimum 3+ years of relevant experience with a Bachelor's degree; or equivalent education and experience; Or an advanced degree with no previous professional experience.Where required, the role must hold an appropriate degree in the industry (eg. Legal)
Preferred Qualifications- Interventional Radiology/Cardiology or ICU experience preferred
- Experience using vascular interventional devices is preferred
- Equivalent combination of education and experience
- Experience in the medical device industry preferred
- Knowledge of Medical Device Complaint Handling and Reporting Regulations
- Department Management could evaluate and substitute any of the educational requirements by demonstrated experience in the field.
- Healthcare Certification and/or license in specific discipline preferred
- Knowledge of product use in a clinical setting preferred
- Excellent written and oral English communication skills
- Proficient investigative and analytical skills
- Computer literate of MS Word, MS PowerPoint, MS Excel preferred
- Ability to interact with individual/groups at all levels, good presentation/training skills
- Ability to identify priorities and function independently
