Director, Global Complaint Handling and Reporting

Work Shift:

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop 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.

ESSENTIAL FUNCTIONS PERFORMED

1. Responsible for the following quality management sub-systems:
* Global Quality Management System (QMS) Architecture.

• Global Customer Complaint and Evaluation processes

• Global Adverse Event Reporting process

• Global Vigilance Reporting process

i. Quality System Architecture consists of physical and electronic systems and processes that are used to manage and control the Merit Global Quality Management System.
2. Evaluates, develops, selects, implements, supports, and maintains physical and electronic Quality Management System tools, processes and systems that support compliance to all domestic (FDA) and international regulatory requirements.
3. Oversees the work of Global Complaint Handling or Post Market Surveillance Specialists. Responsible for the efficient and effective product related complaints including all respective documents and records associated with the Merit Quality Management System.
4. Manages assigned resources by interviewing, hiring, training, conducting performance evaluations, conducting personal development and career path planning, providing effective job performance feedback and where necessary documenting and implementing performance related discipline in accordance with established procedures.
5. Maintains Global Quality Assurance Adverse Event / Vigilance reporting systems specifically focused on region specific reporting timeliness and consistent, compliant process execution. Expected to maintain 100% on time Global AE/Vigilance reporting compliance.

• Global responsibility for evaluation and final determination of all AE/Vigilance reportability decisions.

6. Manages the implementation of any revisions or new implementation of new Enterprise Quality Management Systems for Complaint Handling and Adverse Event Reporting.
7. Manages and facilitates the control, protection, and accessibility of external reference standards, which may include international regulations.
8. Manages the Global process for creating, controlling, revising, accessing, and maintaining master electronic data (e.g., Oracle).
9. Process owner for Unique Device Identifier (UDI) requirements including but not limited to creating, revising, accessing, and maintaining master data, and includes updating / maintaining required regulatory databases as required.
10. Process owner for Quality Planning. The Quality Planning output will define the quality practices, resources, and activities relevant to devices that are designed, distributed and manufactured for or by Merit Medical.
11. Performs other duties, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

* Lifting -- Not to exceed 50 lbs. -- local practice may apply.
* Writing
* Sitting
* Standing
* Bending
* Visual acuity
* Color perception
* Depth perception
* Reading
* Field of vision/peripheral
* Fine motor skills

SUMMARY OF MINIMUM QUALIFICATIONS

* Credentialed clinical professional, Clinician, Registered Nurse or equivalent education and experience to support regulatory determinations of potential clinical harms and complaint evaluation in support of Adverse Event / Vigilance reporting decisions.
* Work related experience within Medical Device or similar regulated industry consisting of six years direct experience. Three years of direct experience in a supervisory, management or leadership capacity is highly desired.
* Demonstrated computer skills preferably Auto Cad, spreadsheets, word processing, database and other applicable software programs.
* Knowledge of U.S. FDA regulations (21 CFR 820), the Medical Devices Directive, ISO 13485
Quality System Standards, and Canadian Medical Device Regulation (CMDR), ANVISA, TGA and
JPAL/JGMP.
* Strong interpersonal and cross functional collaboration skills.
* Ability to work across all levels of management and employees to identify and resolve issues.
* Ability to work well as part of Global Quality team to accomplish organizational objectives effectively.

COMPETENCIES

* International Regulatory standards
* Electronic data management systems
* Documentation control
* Quality System process improvement
* Problem solving
* Analytical thinking
* Multitasking
* Time management

COMMENTS

Infectious Control Risk Category III:

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 III states employment and procedures that do not require exposure.

As an eligible Merit employee, you can expect the following:

* Multiple Shifts and Hours to choose from: Days, Swing (Eve), 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 Sick-Time | Paid Holidays

* 401K | Health Savings Account

To see more on our culture, go to www.merit.com/careers.

Military Veterans are encouraged to Apply.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.