Post Market Surveillance Associate I

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.

WORK SHIFT

SUMMARY OF DUTIES

ESSENTIAL FUNCTIONS PERFORMED

1. Assists in performing complaint management, PMS follow up (to closure) of deliverables with all Global process stakeholders.

2. Performs compliance review of Pilgrim records, including performing, reviewing, and approving complaints tasks within the complaint management system.

3. Performs routine PMS tasks including reviewing process metrics and coordinating the timely execution of required documents and deliverables with process stakeholders. Provides PMS process inputs related to complaint management or AE reporting.

4. Performs and assists with complaint evaluations.

5. Reviews clinical literature searches for complaint criteria.
6. Completes and maintains required quality records and complaint files, including complaint logs, complaint files and other required department records. Maintains all documents and files related to the complaint and AE reporting processes.
7. Supports Global Quality and Risk Management practitioners with process data in support of related process deliverables as needed.
8. Oversees day to day activities of the Quality Assurance and Field Assurance technicians related to Field Assurance activities (complaint intake, product receipt, complaint closure), product disposition, corrective action, reports, follow up, etc.
9. Assists with training of Quality Assurance and Field Assurance technicians, SOJTs, LMS, etc.
10. Assists PMS Specialists with PMS deliverables as requested.
11. Leads department Stand-Up meetings / Daily Department Status Meetings when assigned by the department Manager. Determines and communicates daily priorities to team members based on metrics, KPIs and monitoring of incoming work requirements.
12. Assists in preparing reports (prep for Clinical review and approval) for regulatory authorities (EU, FDA, International) as needed.

13. When designated, may act as team lead of the Quality Assurance and Field Assurance technician team, overseeing the complaints process.
14. Performs other duties as requested by the department Manager.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

* Lifting -- Not to exceed 50 lbs.
* Writing
* Sitting
* Standing
* Bending
* Visual acuity
* Color perception
* Depth perception
* Reading
* Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

* Education and/or experience equivalent to a High School Diploma.
* A minimum of five (5) years of relevant work experience.
* Knowledge of Field Assurance, AE Reporting and Post Market Surveillance job duties.
* Demonstrated computer skills, preferably Microsoft Office Suite, DOMO, Oracle, and other applicable software programs.
* Experience in quality data extraction, review, and high-level analysis.
* Skills in engineering data report writing, extraction, processing, and presentation.
* Document review and editing skills.
* Understanding of LEAN and 5S methodologies.

PREFERRED QUALIFICATIONS

* Customer service, Quality Assurance, Field Assurance experience, Post Market Surveillance experience, EU MDR 2017/745 experience.

COMPETENCIES

* Customer service
* Problem solving
* Attention to accuracy and detail oriented.
* Excellent customer service and problem-solving skills.
* Excellent analytical skills and the ability to solve moderately complex technical problems.
* Excellent organizational and interpersonal skills.
* Excellent written and verbal communication skills.
* Ability to work well as a team member.

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 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.