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

DAY (United States of America)

SUMMARY OF DUTIES

Quality Management System process owner with primary responsibility for documenting, training, executing, measuring, and improving process compliance for the quality management sub-systems assigned.

ESSENTIAL FUNCTIONS PERFORMED

1.    Responsible for the following quality management sub-systems:
•    Non-Conforming Material Report (NCMR)
•    Corrective and Preventive Action (CAPA)
•    Global Internal Audit Program
2.    Responsible for managing all Quality Events and assuring that QMS process feeder systems are developed to document, manage, track, trend and compliantly resolve quality issues. 
3.    Responsible for documenting, assessing potential impact, planning, managing and compliantly resolving deviations to established QMS procedures. 
4.    Documents, implements, and maintains compliant quality management sub-systems to assure effective operational execution of assigned responsibilities across all Global sites and locations. Evaluates implements and continuously improves manual or electronic tools and systems to support timely and effective completion of required process deliverables. 
5.    Develops, implements, and measures key performance metrics directly associated with effective operational execution of assigned responsibilities. 
6.    Provides Subject Matter Expertise and Training / development requirements and objectives for assigned areas of responsibility.  
7.    Works in close collaboration and partnership with cross functional and cross Site Global Quality Assurance stakeholders to optimize overall operational efficiency and effectiveness while maintaining & developing best in class quality systems.
8.    Manages the Global Internal Audit process including but not limited to the internal audit schedule, internal audit schedule change / review / approval, development, and documentation of QMS internal audit elements and audit objectives (audit scope), process and product audit checklists and tools, internal auditor roster and resource management, auditor qualification training, and Global training content development. 
9.    Maintains Global Non-Conformance Material Report (NCMR) system including but not limited to required QMS documentation, electronic tools and feeder systems, and practitioner training content.
10.    Maintains Global Corrective and Preventive Action (CAPA) system including but not limited to required QMS documentation, electronic tools and feeder systems, and practitioner training. 
11.    Assesses Quality Events to determine potential impact. Determines feeder systems into NCMR, CAPA or other appropriate quality management sub-system to assure that quality events are effectively documented, assessed, evaluated, dispositioned, resolved and quantified or measured (focus on reduction / elimination). 
12.    Assesses Deviations to established QMS process requirements. Designs, creates, documents, implements, assesses regulatory impact, and produces training content to assure deviations are resolved and closed in a timely manner. 
13.    Prepares for, participates in and assists with FDA facility inspections, Notified Body Audits, Post Market Surveillance activities and other governmental inspections as necessary. 
14.    Maintains appropriate records and metrics for assigned responsibilities. 
15.    Identifies opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance, increase the value of products, or increase customer satisfaction.
16.    Manages assigned resources by interviewing, hiring, and firing, 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.  
17.    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

SUMMARY OF MINIMUM QUALIFICATIONS

•    Education and/or experience equivalent to a Bachelor’s Degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential (NFQ Level 7, or higher).
•    At least eight (8) years of work-related experience, of which a minimum of four years’ experience in a related supervisory, leadership or management role. 
•    Proven track record in leading organizations through external inspections / audits (e.g. FDA, Notified Bodies, Regulatory Agencies, Competent Authorities, and Customers).
•    Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), Medical Device Regulation MDR EU 2017/745, ISO 13485 Quality System Standard, Medical Device Single Audit Program, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), ANVISA, TGA and JPAL/JGMP.
•    General knowledge of the medical device industry and the applications of Merit's products in the medical field.
•    PC skills including standard offices packages as well as ability to understand and learn customized computer software programs.
•    Excellent communications skills to include oral and written fluency in English and local language as deemed appropriate.

PREFERRED QUALIFICATIONS

•    Post graduate diploma/Master’s degree in Quality Management.
•    Demonstrated aptitude for process improvement and use of Lean and Six-Sigma resources and tools.
•    Strongly prefer medical device manufacturing management experience.
•    Strongly prefer proven track record leadership experience in the development of a large, international team, in multiple regions.  

COMPETENCIES

•    Strong leadership ability and the ability to influence at all levels within the organization.
•    Demonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate and empower others.
•    Ability to provide functional, cross functional and organizational leadership as required by the demands of the role.
•    Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident at all levels, internal and external. 
•    Excellent data, analysis, trends, and reporting skills.  Ability to read and interpret documents.
Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and work flows.  Presents numerical data effectively.  Attention to detail without losing site of the big picture.
•    Identifies and resolves problems in a timely manner; develops alternative solutions; works well in a group problem solving situations; presents ideas and information in a manner that gets others' attention; displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions includes appropriate people in decision-making process.  
•    Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation. 
•    Demonstrates organizational values in carrying out of all assigned responsibilities/tasks.

COMMENTS

Infectious Control Risk Category II:

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.