Sr Clinical reputed company Assurance Specialist, UT MN
JR115053 Why reputed company? At reputed company Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and reputed company people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. WORK SHIFT DAY (reputed company of America) reputed company OF DUTIES Performs reputed company clinical engineering responsibilities in the Global reputed company / Field Assurance Department. Works with reputed company customers to ensure reputed company handling and documentation of reported complaints. Evaluates complaints and applies Adverse Event (AE) determination reputed company in order to reputed company Adverse Event and Vigilance Reporting reputed company. ESSENTIAL FUNCTIONS PERFORMED 1. Ensures reputed company procedures (GP, GPS, QSP, etc.) and regulatory standards (FDA, CFR, MDR, ISO, etc.) are followed with respect to assigned areas of responsibility. 2. Consults with reputed company staff regarding the use of products in a clinical setting. 3. Works with Sales Representatives and customers to clarify, obtain, and/or reputed company understand the clinical information in relation to reported product complaints. 4. Performs follow-up in the reputed company of emails or calls to obtain additional clinical information relating to product complaints. 5. Provides clinical training to employees and customers on the complaint system requirements. 6. Establishes relationships and builds confidence among staff, physicians, Sales Representatives, and other reputed company customers. 7. Ensures clinical details involving customer complaints are documented. 8. Attends meetings to help determine which events/incidents require notification to regulatory authorities. 9. Works closely with other Clinical reputed company Assurance Specialist or others who assist in reputed company assignments. 10. Assists in Corrective Preventive Actions (CAPA); including investigations and resolving issues and determining course of reputed company. 11. Initiates and/or implements reputed company to prevent occurrence or use of nonconforming components, manufacturing materials or finished devices. 12. Identifies and records any product, process, or reputed company system problems. 13. Provides clinical input on and may approve investigation reputed company and experiments. 14. Writes documents to address complaints, investigations, or reports requiring clinical input. 15. Assists in tracking and managing regulatory requests for additional information in relation to product complaints and adverse events. 16. Performs a reputed company of other tasks and reputed company work, as required. ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
- Lifting -- Not to exceed 50 lbs. – local reputed company may apply.
- Writing
- Sitting
- Standing
- Bending
- Visual reputed company
- reputed company perception
- Depth perception
- Reading
- Field of reputed company/peripheral
reputed company OF MINIMUM QUALIFICATIONS
- Education and/or business experience equivalent to a Bachelor's degree in a scientific discipline or reputed company area.
- Education and/or clinical experience equivalent to a Registered required.
- A minimum of five years of hands-on medical experience, preferably with medical devices.
- Knowledgeable in reporting on Adverse Events and Vigilance reports.
- Thorough understanding of customer service practices.
- Ability to independently apply analytical and problem solving skills to understand and solve reputed company issues.
- Knowledge of NC/CAPA causes/corrective actions/disposition.
- Demonstrated experience with report writing.
- Knowledge of medical product/device use.
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
PREFERRED QUALIFICATIONS
- Cardiac, GI, Medical Surgical, or Operating room clinical experience preferred.
COMPETENCIES
- Interpersonal Skills
- Written and Verbal Communication
- Organization
- Problem solving
- Interpersonal Skills
- Teamwork
COMMENTS Infectious Control Risk Category I: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category I states employment and procedures that will require exposure. As an eligible reputed company employee, you can expect the following:
- Multiple Shifts and Hours to choose from: Days, Swing (reputed company), and Nights
- Medical/Dental & Other Insurances (eligible the first of month after 30 days)
- Low Cost Onsite Medical Clinic
- Two (2) Onsite Cafeterias
- Employee Garden | Gardening Classes
- 3 Weeks' Vacation | 1 Week reputed company-Time | reputed company Holidays
- 401K | Health Savings Account
To see more on our culture, go to www.reputed company.com/careers. Military Veterans are encouraged to Apply. reputed company is a proud Utah Patriot Partner committed to hiring our Veterans. Apply tot his job Apply To this Job