Work Shift:

DAY

Work Schedule:

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

•           Accountable for management of the Quality Organizations.

•           Consistent application of Quality System standards (for example ISO 13485, ISO 9001, and 21CFR820).

•           Maintains and improves the Site Quality System.

•           Leads and supports site’s CAPA – Effective use of DMAIC process to support CAPA process, detail technical review and approval of the CAPAs to ensure compliance to standard and effectiveness.

•           Continuously evaluates progress toward Distribution Quality objectives, adapting them to meet customer and business needs.

•           Recommends and initiates projects to resolve nonconforming issue(s), facilitates root cause analysis discussion using appropriate quality tools (for example Fishbone Diagram, 5-Whys), development corrective and preventative action.

•           Accountable for non-conforming product (hold, damages, donation, scrap) processes.

•           Understands Quality Systems Regulatory requirements and application to Company.

•           Develops and executes Global Quality Distribution Operations strategy.

•           Oversees site’s training program and Quality Management System, ensuring that the processes needed for QMS are effectively established, implemented, and maintained in accordance with standard and company’s policy and procedures.

•           Manages and/or supports the risk management, quality system documentation, and validation and verification for new or change process.

•           Handles customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.

•           Maintains positive and cooperative communication and collaboration with all levels of management, employees, customers, contractors and vendors.

•           Collaborates with cross functional partners to seek their input into the development of policies and procedures, and their support in addressing Quality Issues.

•           Guides the successful completion of major programs and may function in a project leadership role for site, regional or corporate initiatives/projects.

•           Establishes, manages and monitors metrics which effectively measure the performance of the Global Distribution QMS and ensures appropriate actions are taken and assessed on a regional basis to maintain established targets.

•           Ensures talent retention and performance management of team.

•           Mentors and develops site Quality leadership, including dedicated succession planning and contingency management.

•           Performs a variety of other tasks and related work, 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

SUMMARY OF MINIMUM QUALIFICATIONS

Education and/or experience equivalent to a BS Degree in Quality Engineering or related discipline.Fifteen years’ Quality experience in Medical Device and/or Pharmaceutical regulated industry.Experience in Supply Chain and/or Distribution Center Operations preferredKnowledge and experience with Medical Device regulations, ISO 13485 and 21 CFR 820ISO 13485 and 21 CFR 820 Lead Auditor certified preferred.Computer skills (Excel, Word, Power Point, etc.)

PREFERRED QUALIFICATIONS

•           Demonstrated successful organizational influence in areas including, but not limited to, compliance excellence, continuous improvement, product-related risk mitigation, and/or manufacturing process capability enhancement

COMPETENCIES

•           Strong verbal and written communication skills with the ability to provide diligent, concise, and fact-based communication to Executive Management, cross-functional peers, and your direct report team

•           Strong leadership, decision-making, problem-solving, continuous improvement, and management skills with the demonstrated ability to create momentum and deliver results in a timely manner by prioritizing personal workloads, as well as providing guidance, direction, and oversight to others

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.